INMETRO ORDINANCE 384-20

Prévia do material em texto

[Coat of Arms] Federal Public Service 
MINISTRY OF INDUSTRY, FOREIGN TRADE AND SERVICES 
NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY - INMETRO 
 
 
ORDINANCE No. 384, DATED DECEMBER 18, 2020 
 
It approves the Compliance Assessment Requirements 
for Equipment under Health Surveillance Regimen - 
Consolidated. 
 
The PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, QUALITY AND 
TECHNOLOGY - INMETRO, in the exercise of the power granted to it by articles 4, paragraph 2, of 
Law no. 5.966, dated December 11, 1973, and 3, clauses I and IV, of Law no, 9.933, dated 
December 20, 1999, combined with what is provided in articles 18, clause V, of Annex I of Decree 
no. 6.275, dated November 28, 2007, and 105, clause V, of Annex to Ordinance no. 2, dated 
January 4, 2017, of the former Ministry of Industry, Foreign Trade and Services, considering what 
Decree no. 10.139, dated November 28, 2019 determines, and what is provided in SEI Process no. 
0052600.006080/2019-60, decides: 
Object and scope of application 
Article 1. The Compliance Assessment Requirements and the Specifications for the 
Compliance Identification Seal for Equipment under Health Surveillance Regimen - Consolidated, 
set, respectively, in Annexes I and II available at http://www.inmetro.gov.br/legislacao. remain 
approved. 
Paragraph 1. The compliance assessment, through the certification mechanism, must be 
conducted by a Product Certification Body - PCB, established in Brazil and accredited by Inmetro, 
in harmony with the presently approved Requirements. 
Paragraph 2. These Requirements apply to equipment, including their parts and 
accessories, for medical, dental, laboratory or physiotherapeutic purpose, used directly or 
indirectly for diagnosis, treatment, rehabilitation and monitoring in human beings, and to 
equipment for the purpose of embellishment and aesthetics. 
Paragraph 3. Equipment that are not classified in Anvisa RDC no. 27, of 2011 or 
substitutive resolution are excluded from the scope of application of these Requirements. 
Paragraph 4. The definition, through Normative Instruction - IN or Collegiate Board of 
Directors Resolution - RDC, with regard to the requirement - compulsory character - of the 
certification of Equipment under Health Surveillance Regimen lies with the National Health 
Surveillance Agency. 
Article 2. The technical regulation of equipment under health surveillance regimen, as 
well as the exercise of power of administrative policy with regard to the object is not within the 
scope of Inmetro's legal competence, attributing, solely, the supervision with respect to the use of 
the brand, having as focus the fulfillment of the Compliance Assessment rules. 
Terms and transitory provisions 
Article 3. Within a maximum period of 6 months, from the effective date of this 
Ordinance, new certificates can only be issued based on the presently approved Requirements. 
Article 4. For certificates already issued based on Inmetro Ordinance no. 54, of 2016, the 
http://www.inmetro.gov.br/legislacao
Page 2 of Ordinance nº 384/Presi, dated 18/dec/2020 
certificates, for inclusion of the reference to the presently approved Ordinance, in the 
maintenance following the publication of this Ordinance, provided that this does not occur in a 
period of less than 6 (six) months, when they are still able to satisfy Ordinance No. 54, of 2016. 
Article 5. For the purposes of feeding the Certified Products and Services Bank - ProdCert, 
the Product Certification Bodies must complete the mandatory field "validity of the certificate" 
with a period of 5 (five) years, counted from the date of issue, with revalidation every 5 (five) 
years, in order to maintain the “active” status of the certificate, until the system is modified, when 
at that moment the validity will become “indeterminate”. 
Article 6. The maintenances of certifications or re-certifications that started until April 30, 
2017 could still be carried out based on Ordinance 350, of 2010 until the limit of validity of 5 (five) 
years of the certificates issued until April 30, 2018. 
Sole paragraph. The validity of the certificates issued in accordance with the caput may 
expire in advance if the Product Certification Body (OCP) or Anvisa identifies that the 
manufacturer has modified the design, critically affecting the safety of the equipment. In this case, 
the original certificate is canceled and the manufacturer is required to adapt the equipment to the 
requirements of the presently approved ordinance for a new certification. 
Article 7. A transition period is established for the dismemberment of certificates issued 
for identical products, manufactured in different sites (plants), into individual certificates as 
established by Inmetro Ordinance no. 118, of 2015 and the presently approved Ordinance, which 
ends in 50 (fifty) months, counted from the effective date of this Ordinance. 
Article 8. The PCB must inform Inmetro and Anvisa of the occurrences according to sub-
items 6.3.3.5 and 6.3.4.1 of the RAC (acronym in Portuguese for Compliance Assessment 
Regulation) approved by this Ordinance, as well as the design modifications that have been 
identified in audits and have not been informed by the manufacturer to the PCB as presently 
established, that critically affect the safety of the already certificated Equipment under Health 
Surveillance. 
Paragraph 1. Communications to Anvisa must be carried out through the electronic 
address certifica.eletromedicos@anvisa.gov.br. 
Paragraph 2. Communications to Inmetro for equipment under metrological control must 
be carried out through the electronic addresses dicol@inmetro.gov.br. 
Paragraph 3. Communications to Inmetro for equipment without metrological control 
must be carried out through the electronic address divet@inmetro.gov.br. 
Revocation clause 
Article 9. The following Inmetro Ordinances are hereby revoked: 
I - no. 350, dated September 6, 2010, published in the Federal Official Gazette on 
September 9, 2010, section 1, page 67, on April 30, 2023; 
II - no. 54, dated February 1, 2016, published in the Federal Official Gazette on February 
2, 2016, section 1, pages 70 to 71, within 6 (six) months from the effective date of this Ordinance; 
and 
III - no. 544, dated November 24, 2016, published in the Federal Official Gazette on 
November 29, 2016, section 1, page 41, within 6 (six) months from the effective date of this 
Ordinance. 
 
mailto:certifica.eletromedicos@anvisa.gov.br
mailto:dicol@inmetro.gov.br
mailto:divet@inmetro.gov.br
Page 3 of Ordinance nº 384/Presi, dated 18/dec/2020 
Article 10. This Ordinance becomes effective on December 28, 2020, according to article 4 
of Decree no. 10.139 / 2019. 
 
 
MARCOS HELENO GUERSON DE OLIVEIRA JÚNIOR 
President 
 
INMETRO ORDINANCE ANNEX No. 384/2020 
1 
 
ANNEX I - COMPLIANCE ASSESSMENT REQUIREMENTS FOR 
EQUIPMENT UNDER HEALTH SURVEILLANCE REGIMEN 
 
1. OBJECTIVE 
To establish the compliance assessment criteria and procedures for Equipment under Health 
Surveillance Regimen, with focus on safety, through the certification mechanism, aiming at 
accident prevention. 
 
1.1 GROUPING FOR CERTIFICATION PURPOSES 
The certification of Equipment under Health Surveillance Regimen must be conducted by family, 
which is defined according to the criterion determined by Annex C of this RAC (Compliance 
Assessment Regulation). 
 
 
2. ACRONYMS 
For the purposes of this RAC, the following acronyms are adopted, complemented by the 
acronyms contained in complementary documents mentioned in chapter 3 of this RAC: 
 
RMF Risk Management File 
Anvisa National Health Surveillance Agency 
CGMP Certificate of Good Manufacturing Practices 
CNPJ Corporate Taxpayer Identification Number 
EM Electromedical 
Note: It includes the category of non-electrical equipment under Health Surveillance 
Regimen RM Risk Management 
IN Anvisa Normative Instruction 
PM Protection Media or Measures 
OPM Operator ProtectionMedia or Measures 
PPM Patient Protection Media or Measures 
SDP Software Development Plan 
RDC Collegiate Board of Directors Resolution 
DHF Design History File 
DHR Device History Record 
DMR Device Master Record 
SOUP Software of Unknown Provenance 
INMETRO ORDINANCE ANNEX No. 384/2020 
2 
RMS Risk Management Summary 
 
3. COMPLEMENTARY DOCUMENTS 
For the purposes of this RAC, the following complementary documents are adopted. 
Inmetro Ordinance 
no. 118 or substitutive 
ordinance 
6/3/2015 General Product Certification Requirements (GPCR) 
Inmetro Ordinance 
no. 46 or substitutive 
ordinance 
1/22/2016 
Technical Metrological Regulation for non-invasive 
measuring sphygmomanometers 
Inmetro Ordinance 
no. 402 or substitutive 
ordinance 
8/23/2019 
Technical Metrological Regulation for digital clinical 
thermometers 
Anvisa IN no. 49 or 
substitutive 
instruction 
11/22/2019 
It approves the list of Technical Standards that must be 
adopted for certification of compliance, within the scope 
of the Brazilian Compliance Assessment System (SBAC), 
for equipment under Health Surveillance regimen, in the 
terms of ANVISA RDC Resolution no. 27, dated June 21, 
2011. 
Anvisa RDC no. 16 or 
substitutive resolution 
3/28/2013 
It provides on the requirements of Good Manufacturing 
Practices and Good Practices for Medical Products and 
Products for In Vitro Diagnostic Use. 
Anvisa RDC no. 23 or 
substitutive resolution 
4/4/2012 
It provides on obligatory of execution and notification of 
field actions by healthcare product registration holders in 
Brazil. 
Anvisa RDC no. 27 or 
substitutive resolution 
6/21/2011 
It provides on the procedures for compulsory certification 
of equipment under Health Surveillance Regimen. 
Anvisa RDC no. 67 or 
substitutive resolution 
12/21/2009 
It provides on the technovigilance standards applicable to 
healthcare product registration holders in Brazil. 
ABNT NBR IEC 60601 
Electromedical Equipment, parts 1 and 2, general 
requirements and specific requirements; internalized 
standards of the IEC 60601 series 3rd edition, including 
their amendments and errata 
ABNT NBR ISO 80601 
Electromedical Equipment, specific requirements; 
internalized standards of the ISO 80601 series, including 
their amendments and errata. 
ABNT NBR ISO 13485:2016 
Healthcare products - Quality management system - 
Requirements for regulatory purposes. 
ABNT NBR ISO 14971:2009 
Healthcare products - Application of risk management to 
healthcare products. 
ANVISA RDC no. 81 or 
substitutive resolution 
11/5/2008 
It provides on the Technical Regulation of Imported 
Goods and Products for Health Surveillance purposes. 
 
3.1 The general standard, collateral standard and specific standard must be in equivalent 
versions for use. 
INMETRO ORDINANCE ANNEX No. 384/2020 
3 
3.2 In cases where an update of the Standard occurs, compliance with the Standard of the 
current ANVISA Normative Instruction continues to be compulsory, and the updated standard, 
alternatively, can be used. 
3.3 Normative items referred to in this RAC, in case of an update of the ANVISA Normative 
Instruction or if the manufacturer (or applicant) uses an updated standard, they can be substituted 
by equivalent items of the normative update. 
3.4 New technologies and deviations in the normative base: 
The development of new technologies can, in some cases, change the application of a standard, 
change the limits established by a standard, or even cancel its application. The justification of the 
deviation from the testing methodology in the RMF, DMR or DHF lies with the manufacturer. 
3.5 Evaluation of new technologies when there is evidence of deviation from the normative base: 
3.5.1 The PCB should always ask the manufacturer about the reasons for deciding whether to 
change or not the application of a specific standard at the preparation stage of the Test Plan. 
3.5.2 The PCB must verify and confirm, in the Test Plan, if the manufacturer's analysis and 
justification for normative deviation are correct or, otherwise, include the missing tests for 
compliance assessment of the specific standard in the Test Plan. 
3.5.3 The PCB must ensure that, regardless of the innovative character of the product, the tests 
performed guarantee sufficient electrical, mechanical, thermal, chemical, and electromagnetic 
safety to attest to the safety of the equipment. 
 
 
4 DEFINITIONS 
For the purposes of this RAC, the definitions below and those contained in the complementary 
documents mentioned in item 3 are adopted: 
 
4.0 Risk Management File 
The Risk Management File (RMF) is the fundamental file in the prioritize of management of the 
products' risks, as result of analysis and evaluation, for the definition of acceptability, treatment 
and control that must be given to each of the identified hazards or dangerous situations for an EM 
product or system. It serves to provide traceability to the application of the items of ABNT NBR ISO 
14971 (clause 3.5 of ABNT NBR ISO 14971) and supports the prioritization of corrective actions, in 
addition to containing the record of all or any change to the design. The RMF is, in most cases, 
fragmented and may not be seen in a single place (summary), for example, the part referring to 
software risk management which, in almost all cases, should be audited only at the factory due to 
the protection of the manufacturer's Intellectual Property. The RMF must provide traceability for 
each identified hazard and also minimally correlate all the requirements of the standards 
applicable to the product that were established by Normative Instruction, and its risk management 
process (analysis, evaluation, control and monitoring) in compliance with the ABNT NBR ISO 
14971, including hazardous situations that were not foreseen by the standards applicable to the 
product, but that were identified as relevant during the risk analysis. 
 
4.1 Technical Assistance 
Technical assistance: Maintenance or repair of a finished product for the purpose of restoring it 
back to its specifications [Anvisa, RDC no. 16 of 2013, item 1.2.1]. 
INMETRO ORDINANCE ANNEX No. 384/2020 
4 
4.1.1 Technical Assistance - Extended definition [Inmetro]. 
It is the process in which a professional, with knowledge of specific technical content, provides 
information and clarifications or performs actions to meet identified needs including maintenance 
or repair of a finished product in order to restore it back to its specifications: 
4.1.1.1 It allows the collection of information pertinent to the object in question for 
improvement of designs, improvement of quality, efficacy and efficiency of products, processes or 
services. 
4.1.1.2 It contributes towards the competitiveness of companies in the market, as well as the 
strengthening of their quality management systems. 
4.1.1.3 It depends directly on the competencies and skills developed by its employees, through 
qualifications and trainings, as well as through material resources provided for their execution. 
4.1.1.4 It needs a high priority in quality management systems, demonstrated by the repeated 
use of efforts with customers in the solution of problems. 
4.1.1.5 A structure is recommended characterized by: 
a) use of executing people who show knowledge and skill; 
b) constant assessment of the qualification of executors in the application of knowledge for 
satisfaction of customers' needs; 
c) use of recognized "best practices" and relevant standardizing or regulatory documents as 
response to specific problems; and 
d) use of diverse means of communication with the customer. 
 
4.2 Original characteristics 
They comprise the technical specifications, indication and purpose of use, physical characteristics, 
including the list of critical components and accessories, chemical characteristics (when 
applicable), the content of supporting documents and the markings on the equipment, which 
constitute the design characteristicsof an equipment at the moment of concession of the 
product's certification, it must also correspond to the characteristics of the equipment regularized 
at Anvisa, or to be regularized at Anvisa. 
 
4.3 Critical component 
Component that directly affects the safety of the patient and / or user. 
 
4.4 Usability Engineering 
Application of knowledge about human behavior, skills, limitations and other characteristics for 
the design of equipment or electromedical system to achieve adequate usability. [ABNT NBR IEC 
62366: 2010 Amendment 1: 2016, definition 3.8] 
 
4.5 Routine (or production) testing 
Non-destructive test, carried out by the manufacturer, which provides proof of compliance for a 
manufactured batch, at any given time, performed on a manufactured product, at the end or in 
the course of a production line, to demonstrate that the product was assembled according to the 
design requirements and the conditions specified by this RAC. 
 
4.6 Type (or qualification) test 
Test, destructive or not, which provides proof of compliance of an item, at a given time, 
performed on one or more units of a product, to demonstrate that this product meets the 
requirements specified in the design and meets the established evaluation requirements based on 
national (ABNT), regional and international standards, and the conditions specified by this RAC. 
INMETRO ORDINANCE ANNEX No. 384/2020 
5 
 
4.7 Large equipment for diagnosis or therapy 
Health application equipment used for diagnosis or therapy, of permanent installation in an 
environment specially built / adapted for its operation, with an individualized and specific power 
supply network, requiring maintenance actions to be carried out at its installation site. Its 
installation is carried out by a specialized team, generally requiring formal commissioning for its 
approval. 
Note: interventional x-ray, nuclear medicine, computed tomography and magnetic resonance 
equipment constitute large equipment, however it is not limited to these. 
 
4.8 Manufacturer 
Legal entity responsible for the design, manufacture, assembly, transformation or processing of a 
finished product or system, packaging and labeling of a medical product, before being placed on 
the market or in operation, regardless of whether such operations are carried out by that entity or 
on its behalf, by a third party. 
 
4.9 Contract Manufacturer 
Outsourced company, duly established as a legal entity, which carries out the industrialization of a 
medical product under the responsibility of a Legal Manufacturer, by means of a legally 
established contract. 
Note: Contracted Manufacturer derives from the English term “Contract Manufacturer” (CM). 
 
4.10 Legal Manufacturer 
Legal entity responsible for the design, manufacture, packaging or labeling of a medical product, 
assembly of a system or adaptation of the product before it is placed on the market or put into 
operation, regardless of whether such operations are carried out by that entity or on its behalf, by 
a third party. 
 
4.11 Family 
Family characterization is as provided for in Annex C of this RAC. 
 
4.12 Risk Management 
Systematic application of management policies, procedures and practices to risk analysis, 
assessment, control and monitoring tasks. [ABNT NBR ISO 14971: 2009, item 2.22] 
 
4.13 Anvisa Normative Instruction – IN 
It is a normative act of the Anvisa Collegiate Board of Directors that establishes, on an exceptional 
character, technical requirements to be met by an object. 
 
4.14 Master list of quality documents 
This list is the index or equivalent procedures where all the documents of the quality system 
(procedures, work instructions, etc.) are listed and the versions of the documents in force are 
indicated. 
 
4.15 Protective means 
For an electromedical equipment or system connected by a structured cabling system, the 
manufacturer must declare the means of protection employed to reduce the risk from electric 
shock (PM), which is divided into two classes: means of reducing the risk of electric shock to the 
INMETRO ORDINANCE ANNEX No. 384/2020 
6 
patient (PPM); and means of reducing the risk of electric shock to the equipment operator (OPM). 
 
4.16 Serial or batch number 
Different combination of letters or numbers, or both, from which the complete history of 
purchases, manufacture, packaging, labeling and distribution of finished products can be 
determined. [RDC 16 03/28/2013, item 1.2.15] 
 
4.17 Essential production process 
It is the method, system or set of indispensable activities for the generation of a product, with a 
certain critical purpose, applied from the beginning to the final delivery of the product. 
 
4.18 Design History File (DHF) 
Compilation of records containing the complete design history of a finished product. 
 
4.19 Device Master Record (DMR) 
Compilation of documents containing specifications, instructions and procedures for obtaining a 
finished product, as well as installation, technical assistance and maintenance. 
 
4.20 Applicant 
Legal entity, public or private, national or foreign, legally established in the country, with CNPJ, 
that develops at least one of the following activities: production, assembly, creation, construction, 
transformation, importation, free distribution or not, or sale of equipment under Health 
Surveillance regimen, covered by this RAC. It is responsible for requesting product certification 
with the PCB, it is responsible for ensuring the performance of the tests provided for in this RAC, it 
holds the concession of use of the Compliance Identification Seal, and it is responsible for 
regularization with Anvisa. The term supplier or applying supplier employed in the GPCR refers, in 
this RAC, to the certification applicant. 
 
4.21 Pilot or Production Unit 
The pilot or production unit corresponds to a product unit or set of produced units obeying the 
production process criteria established in the product design. The pilot unit uses the materials that 
will be used in the production of the product and the exclusive process and tools necessary for its 
manufacture, and is built after a complete risk management analysis, by the manufacturer, 
through evaluation and tests prior to certification. 
 
 
5 COMPLIANCE ASSESSMENT MECHANISM 
The Compliance Assessment Mechanism used in this document is Certification, applicable to 
Equipment under Health Surveillance Regimen contemplated by this RAC. 
 
 
6 COMPLIANCE ASSESSMENT STAGES 
 
INMETRO ORDINANCE ANNEX No. 384/2020 
7 
The compliance assessment process consists of several stages and each stage obeys a sequence of 
procedures. This chapter establishes the compliance assessment process, which must follow the 
requirements of the GPCR, as amended or supplemented by this RAC. 
 
6.1 Definition of the Certification Model used 
This RAC establishes the certification based on the Certification Model 5 - Type test, evaluation 
and approval of requirements of the manufacturer's Quality Management System, follow-up 
through audits on manufacturers and certification applicants, and tests on sample(s) taken from 
the manufacturer or conditioned by the manufacturer by determination of the PCB, in accordance 
with this RAC, traceable, representative of the design and pilot production, conditioned by 
evaluation, audit and approval of the product's Risk Management carried out by the manufacturer. 
 
6.2 Initial Evaluation 
The criteria for Initial Certification Assessment must follow the prescriptions of the GPCR and can 
be changed or supplemented by this RAC and ANVISA Normative Instructions in force. 
 
6.2.1 Certification Request 
The Certification Request begins with the request for a budget for certification and the criteria for 
the Certification Request must follow the requirements of the GPCR, observing the standards and 
deadlines established by Normative Instruction No. 49, of 2019 or substitutive instruction, 
complemented by this RAC. 
 
6.2.1.1 Requirement6.2.1.1 of the GPCR applies fully. 
 
6.2.1.2 The sub-items of requirement 6.2.1.2 of the GPCR apply as indicated below. The 
beginning of the certification process is conditioned to a formal manifestation by the applicant 
made directly to a Product Certification Body accredited and / or designated by Inmetro within the 
scope of this RAC, of its choice. The PCB must be legally established in Brazil and the manifestation 
accompanied by the delivery of documentation meeting the following requirements: 
 
a) The request stage begins with the preliminary analysis of the request for evaluation, by the 
PCB, of the feasibility of the certification. This step must meet the requirements 6.2.1.2.1 of this 
RAC. 
 
b) After the agreement of the PCB and the certification applicant, for the start of the certification 
process, other documents must be presented. For approval by the PCB, at this stage, adjustments 
to the documentation required in this RAC may occur whenever additional requirements 
necessary for certification are identified. If any of the documents mentioned in 6.2.1, from this 
stage on, is not presented or is not presented in the definitive form by the applicant when the 
submission of the documentation takes place; and provided that this fact does not interfere with 
the other stages of the Initial Assessment process, the fact must be documented and registered by 
the PCB and the conclusion of the certification will only occur when all documents are in their final 
form and duly analyzed by the PCB, and the results of this analysis recorded by the PCB. 
 
6.2.1.2.1 Sub-items (a), (d), (g), (l) and Notes (1) and (4) of the requirement 6.2.1.2 of the GPCR 
apply in full, the application in this RAC of sub-items (c), (h), (i), (j), (m), (o), (p), (q), (s) and Note (5) of 
requirement 6.2.1.2 of the GPCR are totally excluded, and the other clauses of sub-item 6.2.1.2 of the GPCR 
apply with new text for this RAC, as follows. 
INMETRO ORDINANCE ANNEX No. 384/2020 
8 
6.2.1.2.2 Item (b) with the following text applies. 
List of model(s) that comprise the family object of certification, obeying the rules of family 
formation established in Annex C of this RAC, when the certification is by family, referring to its 
technical description(s) and including the list of all marketed brands; 
 
6.2.1.2.3 Item (e) applies in full, complemented by: 
The list of technical standards, with justifications, defined by the manufacturer as applicable to the 
product; the identification, with justifications, whether or not the product is part of a family; the 
identification, with justifications, if the product is or is part of an electromedical system; and the 
description of the products that are part of the system, if applicable, are part of the "Descriptive 
Specification". 
 
6.2.1.2.4 Item (f) applies totally complemented with the following text: 
The product user manual, draft or final version must be submitted to the PCB in accordance with 
ABNT NBR IEC 62366:2010, or substitutive standard, item 6 and must include a summary of the 
application specification of the health product (according to requirement 5.1). 
 
6.2.1.2.5 The application of the corresponding item (k) of the GPCR in this RAC is replaced by 
the following text: 
k) Identification of the manufacturer, contract manufacturer, and / or legal manufacturer, when 
applicable, with full address, including the manufacturing unit(s) to be certified, based in another 
country; 
 
6.2.1.2.6 The application of the corresponding item (n) of the GPCR in this RAC is replaced by the 
following text: 
n) Documents referring to the manufacturer's Quality Management System, applicable to the 
object to be certified as provided in Annex B, so that they have been audited by the PCB, as 
provided for in this document. As evidence of compliance with the requirements set out in Annex 
B of that RAC, based on the standard ABNT NBR ISO 13485, the latest audit report of the 
requirements set out in Annex B can be provided for to the certified companies, with valid 
certificates issued by CAB accredited by Inmetro / Cgcre or member of the IAF MLA in accordance 
with ABNT NBR ISO 13485. 
 
6.2.1.2.7 Item (r) applies in full, complemented by the following text: other documents may be 
requested by the PCB for the execution of item 6.2.4 for the definition of the test plan. 
 
6.2.1.2.8 Notes (2) and (3) of item 6.2.1.2 of the GPCR apply with the following text: 
 
Note 2: The photos mentioned in d) must have adequate resolution to enable the evaluation of 
the PCB. 
 
Note 3: It lies with the manufacturer to inform the list of the components considered critical 
mentioned in e), and with the PCB the evaluation of such relationship, and the inclusion of other 
components can occur. 
 
6.2.1.2.9 The manufacturer must provide a summary of the product's Risk Management in 
accordance with item 3 of ABNT NBR ISO 14971, General requirements for the product's risk 
management, and include the documents referring to the manufacturer's Quality Management 
INMETRO ORDINANCE ANNEX No. 384/2020 
9 
System applicable to the object: 
a) Senior management's responsibilities, item 3.2. 
b) Personnel qualification, item 3.3. 
c) Product risk management plan, item 3.4. 
d) Product risk management information, based on item 3.5. 
 
6.2.2 Documentation Compliance and Request Analysis 
The criteria for Documentation Compliance and Request Analysis must follow the requirements of 
the GPCR, complemented as follows. 
 
6.2.2.1 Risk Management File Analysis 
In this phase, the applicant must send to the PCB the parts of the manufacturer's Risk 
Management File that are authorized to leave the factory controlled environment. The portion of 
the RMF content sent must be analyzed by the PCB for the preparation of the audit. In the audit, 
RMF documents that could not be sent (e.g. software) should be audited. The RMF must be 
analyzed by the PCB: 
 
6.2.2.1.1 For the preparation of the manufacturer's audit; and 
 
6.2.2.1.2 For the preparation of the Test Plan, which establishes the necessary tests for the 
Compliance Assessment of the product. The RMF must be accompanied minimally, among other 
documents, whenever applicable, of: 
a) technical product specifications; 
b) electrical layouts of the product; 
c) identification of the functions of the EM system or equipment that constitute essential 
performances; 
d) list of critical components; 
e) selection criteria of high integrity components; 
f) list of certified components and their respective certificates; 
g) inflammability classification for insulating materials; 
h) insulation diagram including PM - PPM and OPM; 
i) comparative tracking indexes of solid insulating materials (CTI); 
j) degree of pollution; 
k) wiring specifications; 
l) insulation class of transformers, motors, electric switches, lamp sockets, etc.; 
m) overvoltage category of the equipment; 
n) list of failures and occurrences; 
o) Usability Engineering file; 
p) policy for determining acceptable risk and acceptability of residual risks; 
q) design calculations of the tensioning safety factor, for equipment with suspended masses; 
r) documentation of the Development Life Cycle for Programmable Electromedical Systems 
(PEMS), with the identification of hazards, risk control, specification of requirements, architecture, 
implementation project, verification, validation, modification and PEMS connection mode to other 
equipment; and 
s) risk management summary. 
 
6.2.3 Initial Audit of the Quality Management System (QMS), Risk Management System (RMS) 
and the Evaluation of the Production Process 
INMETRO ORDINANCE ANNEX No. 384/2020 
10 
 
The application of requirement 6.2.3 of the GPCR in this RAC is completely excluded, and is 
replaced by the following text. 
 
6.2.3.1 The risk management analysis of the product, of the manufacturer, is essential to the 
planning of audits and preparation of the test plan by the PCB. The execution of therequirement 
6.2.3 must take place after this analysis, and item 6.2.3 can be performed concurrently or after 
the completion of requirement 6.2.4. 
 
6.2.3.2 The PCB established in Brazil must prepare the “Audit Plan” and proceed with the initial 
audit of the RMS and QMS at the manufacturing unit during the initial assessment stage. For 
execution of the audits, the PCB can request that it be conducted by a CAB accredited by an MLA 
member body, and it is necessary to prove the outsourcing requirement of ISO / IEC 17065, as if it 
were conducting it. The audits must necessarily take into account all the requirements of Annexes 
A and B of this RAC, with the objective of verifying the conformity of the production process and 
RM. In any case, the results of the audits must be treated and evaluated by the PCB established in 
Brazil. Alternatively, other audits described in 6.2.3.8.2, 6.2.3.8.4 and 6.2.3.8.5 in this RAC can be 
used to comply with the initial audit requirement in the manufacturing unit. 
 
6.2.3.3 The Initial Audits of the Risk Management (RMS) and Quality Management (QMS) 
Systems and the Evaluation of the Productive Process must be performed based on the current 
edition of the standards ABNT NBR ISO 14971, ABNT NBR IEC 60601-1 or ABNT NBR ISO 13485 
respectively, when applicable. Alternatively, other audits described in 6.2.3.8.2, 6.2.3.8.4 and 
6.2.3.8.5 may be used in this RAC to comply with the audit requirement of the manufacturer or 
applicant. 
 
6.2.3.4 The PCB must evaluate the documents and records of the RMS and QMS, and perform an 
audit on the premises of the plant, with the objective of verifying the compliance of the risk 
management, of the production process including the design, the manufacture of the product, and 
the evaluation of the facilities. and staff qualification. The audit must seek the objective 
demonstration that risk management and the production process are systematically and 
effectively monitored, providing evidence of compliance with the product quality and risk 
management requirements established in the RAC. All decisions and analyses, which include or 
exclude activities established in accordance with all items of this requirement, must be evidenced 
in a report. Alternatively, other audits described in 6.2.3.8.2, 6.2.3.8.4 and 6.2.3.8.5 may be used 
in this RAC to comply with the audit requirement of the manufacturing unit. 
 
6.2.3.5 During the audit, the manufacturer must make available to the PCB all documents 
corresponding to the RMS and QMS certification and present the records of the production 
process where the identification of the object of the certification is clearly stated. The PCB must 
review the relevant documentation to ensure that the requirements described in Annexes A and B 
of this RAC have been met. For the audit of certification applicants, in the case of imported 
products, the PCB must analyze the relevant documentation to ensure that the applicable 
requirements described in Annexes B of this RAC have been met. Alternatively, other audits 
described in 6.2.3.8.2, 6.2.3.8.4 and 6.2.3.8.5 may be used in this RAC to comply with the audit 
requirement of the manufacturing unit. 
INMETRO ORDINANCE ANNEX No. 384/2020 
11 
 
6.2.3.6 During the audit, the manufacturer must present, when available, a copy of the reports 
for the assessment of the items of ABNT NBR ISO 14971 and ABNT NBR IEC 60601-1 in Annex A 
and ABNT NBR ISO 13485, in Annex B, of any other evaluation of the system, RMS and QMS audits 
/ inspections, and the records of corrective actions that have been implemented when identified 
and applicable. Alternatively, other audits described in 6.2.3.8.2, 6.2.3.8.4 and 6.2.3.8.5 may be used in 
this RAC to comply with the audit requirement of the manufacturing unit. 
 
6.2.3.7 The RMS audit at the manufacturer is mandatory, however some elements audited can 
be performed outside the factory, at the PCB, if the PCB justifies this action in the audit planning. 
The audit plan should include the search for evidence of aspects of risk management required by 
the preliminary analysis of the RMS in item 6.2.3.1. Documents and records of compliance to meet 
the requirements to be verified at the factory must be obtained and analyzed during the audit. 
The visit date for the audit should be scheduled in agreement with the certification applicant. 
Alternatively, other audits described in 6.2.3.8.2, 6.2.3.8.4 and 6.2.3.8.5 may be used in this RAC to 
comply with the audit requirement of the manufacturing unit. 
 
6.2.3.7.1 The audit should be directed towards the tables in Annex A of this RAC. The RMF must 
demonstrate that: 
 
6.2.3.7.1.1 There are no unacceptable residual risks after all the reiterations generated in risk 
management due to changes made to the design during product development have been 
completed. 
 
6.2.3.7.1.2 The requirements of tables 2, 3, 4, 5, 6 and 7 that can be evaluated by the PCB in its 
documentary form, outside the factory, must be used as elements of the RMS analysis. 
 
6.2.3.7.1.3 The PCB must provide justification for each requirement that is assessed in 
documentary form outside the factory. 
 
6.2.3.7.1.4 The PCB should evaluate the procedures in place for the DMR and DHF. 
 
6.2.3.7.2 The analysis of the results of the audit, of the product tests generated by the analysis of 
the RMF and other relevant information, may lead to the need to carry out new tests or a new 
audit. The RMS analysis can only be completed when all requirements are fully satisfied. 
 
6.2.3.7.3 At the end of the certification process, the PCB must show that all the requirements of 
the standards in tables 2, 3, 4, 5, 6 and 7 were analyzed and met. 
 
Note 1: Statistical production data for manufacturers in Brazil, or foreign manufacturers that are 
starting production of the object of certification, may be available only during the first 
maintenance audit or if an extraordinary audit occurs prior to this. 
Note 2: Statistical production data for foreign manufacturers that already produce the object of 
this certification for other markets must be verified in the initial audit of the plant. 
 
6.2.3.8 QMS Audit and Production Process Assessment 
 
6.2.3.8.1 QMS audit in the manufacturer is mandatory. The audit plan must include the search 
INMETRO ORDINANCE ANNEX No. 384/2020 
12 
for evidences of aspects of the quality management. Documents and records of compliance to 
meet the requirements to be verified at the factory must be obtained and analyzed. The visit date 
for the audit should be scheduled in agreement with the certification applicant. Alternatively, 
other audits described in 6.2.3.8.2, 6.2.3.8.4 and 6.2.3.8.5 may be used in this RAC to comply with 
the audit requirement of the manufacturing unit. 
 
6.2.3.8.2 The audit of the manufacturer's QMS and, when applicable in accordance with that 
RAC, of the requester, must be planned and conducted by the PCB. As an alternative to the PCB 
audit, the following processes may be used: 
a) Evaluation of the last report of ISO 13485, being verified the requirements foreseen in Annex B 
of that RAC; or 
b) Through the analysis of the last audit report, of the requirements provided for in Annex B, 
provided that such Audit report has covered the production line of the product object of the 
certification for certified companies, with valid certificates issued by CAB accredited by Inmetro in 
accordance with ABNT NBR ISO 13485:2016 or substitutive standard; or 
c) Through the compliance analysis of the last audit report of the requirements of Annex B, as 
provided for in ANVISA RDC No. 16/2013 “Certification of Good Manufacturing and Control 
Practices”, for certified companies, with a valid certificate issued by Anvisa. In the analysis, the 
activities evaluation criteria of Table 8 of Annex B - Compliance Assessment Criteria of the 
Activities according to Anvisa RDC 16/2013 must be observed; or 
d) through the audit reportsissued within the scope of the Unified Health Products Audit 
Program (MDSAP in Portuguese for Programa de Auditoria Única em Produtos para a Saúde). In 
the analysis, the activities evaluation criteria of table 8 of Annex B - Compliance Assessment 
Criteria of the Activities according to Anvisa RDC 16/2013 must be observed. 
 
Note: If the product is not in production during the audit period, the PCB must evaluate the QMS 
procedures and records related to the manufacturing process. 
 
6.2.3.8.3 In the case of certification based on a “pilot unit”, it is up to the PCB, during the audit, 
to ensure that the product produced on a scale corresponds to the tested “pilot unit”. 
 
6.2.3.8.4 The Audit Reports of ABNT NBR ISO 13485 or ISO 13485, referring to the Management 
System, conducted by a CAB accredited by an MLA member body can be used for the assessment 
of the QMS, and must be translated into Portuguese if they are in a different language other than 
English or Spanish; or 
 
6.2.3.8.5 The latest audit report, issued by the health authority in accordance with the 
requirements of Annex B, may be used, in accordance with ANVISA RDC No. 16/2013 "Technical 
Regulation for Good Manufacturing Practices for Medical Products and Products for In Vitro 
Diagnostic Use". The report must be analyzed for companies with a valid GMP certification issued 
by ANVISA. In the analysis, the activity assessment criteria of Table 8 of Annex B - Compliance Assessment 
Criteria of the Activities according to ANVISA RDC no. 16/2013 must be observed; or the inspection report 
issued by entities recognized by ANVISA (for example MDSAP) can be used, or the inspection report for 
Class I and II equipment (from ANVISA RDC no. 185/2001 or substitutive resolution) can be used regardless 
of the date of issue, provided that it is accompanied by the manufacturer's statement of compliance with 
ANVISA RDC no. 16/2013. 
 
6.2.3.9 The evaluation of the RMS and QMS of the manufacturing production process may 
INMETRO ORDINANCE ANNEX No. 384/2020 
13 
include more than one product, for technologies, manufacturing instructions and similar assembly 
processes, which may allow the inclusion in an existing certificate or the issuance of a new 
certificate for new products without the execution of a new audit if the following elements are 
met: 
 
6.2.3.9.1 If the initial audit has already taken place, the PCB must verify whether an 
extraordinary audit is necessary to include new products or accessories in an already certified 
product family or for issuance of a new certificate for new products and their accessories. If the 
initial audit did not cover all the manufacturing steps required for the new products, an 
extraordinary audit must be conducted. Alternatively, the assessment of the manufacturing stages 
necessary for certification of new products, from the same production process and manufacturing 
unit, may be included in the next maintenance audit. 
 
6.2.3.9.2 The PCB must record the analysis and justification so that an extraordinary audit is not 
conducted for inclusion of a product to the already certified family of products or for issuance of a 
new certificate for new products and their accessories, and must audit the product's assembly line 
or accessory at the time of the next maintenance audit. 
 
6.2.3.10 Treatment of non-conformities registered during the audits of the Quality Management 
System (QMS), Risk Management System (RMS) and the Evaluation of the Production Process: 
 
6.2.3.10.1 If one or more nonconformities - in any requirement - are identified during the 
performance of the audits, the nonconformity(ies) must be notified by the PCB to the applicant 
who must present an action plan with a defined deadline for the treatment of these identified 
nonconformities. When the action plan or corrective actions involve changes to the product design 
submitted to certification, the applicant shall submit the test plan for the safety impact 
assessment. 
 
6.2.3.10.2 The PCB may, based on the analysis of the corrective action and / or evidence 
presented by the applicant, approve the proposed action plan; however, it may require, if the 
analysis determines, a complementary audit to validate the efficacy of the proposed corrective 
actions. In both cases, the PCB must justify the decision in the report. 
 
6.2.3.11 The audit will be considered complete after all nonconformities have been remedied, 
corrective actions or corrective action plan have been approved by the PCB without pending 
issues. 
 
6.2.3.12 The PCB after the audit must issue a report recording the result of the audit, using this 
RAC as a reference. 
 
INMETRO ORDINANCE ANNEX No. 384/2020 
14 
6.2.3.13 The certification applicant must inform the PCB of changes to the product design, 
materials used or the production process that impact the product's compliance, so that it can 
assess the need for a new audit. 
 
6.2.3.14 The audit report must be signed by at least the audit team, a copy of which must be 
made available to the certification applicant. 
 
 
6.2.4 Definition of the Test Plan 
 
The Initial Test Plan must provide for tests that prove that the object of the conformity assessment 
meets the requirements defined in the normative base established in the ANVISA Normative 
Instruction in force and must be initially agreed between the applicant and the PCB established in 
Brazil. The Initial Test Plan then goes through the laboratory's critical analysis to assess the 
feasibility of execution of the tests. The following requirements must be used for its preparation: 
 
a) The laboratory test methods must follow the precepts of ABNT NBR IEC 17025. 
 
b) The test plan that must contain, at a minimum, the initial tests to be carried out, a clear 
definition of the test methods, number of samples and the acceptance / rejection criteria for these 
tests. 
 
c) The test proposal sent by the applicant for the preparation of the test plan must be analyzed 
by the PCB, whether it is accepted or not. 
 
d) Laboratories must report in the test reports the measurement uncertainties practiced when 
these are relevant to the validity or application of the test results, or when they affect compliance 
with a specification limit. 
 
e) The definition of when the measurement uncertainty values are relevant within the 
certification process is the responsibility of the PCB. When test reports issued by accredited 
laboratories are used, where the uncertainty values are not mentioned, without prejudice to the 
certification process, the PCB should be able to technically justify the absence of the measurement 
uncertainty values. 
 
6.2.4.1 Definition of the Tests to be performed 
 
The Test Plan can be initially suggested by the manufacturer, in accordance with the product's risk 
management. The PCB is responsible for the final preparation of the Test Plan, observing the 
requirements of the applicable standards contained in the Anvisa Normative Instruction in force 
and specific project information contained in the RMF. 
 
6.2.4.1.1 The PCB must analyze the consistency of the documentation presented by the 
applicant in item 6.2.3 for the preparation of the Product Test Plan defined by the summary map 
of risk management and use of previously performed test results, observing the following aspects: 
 
INMETRO ORDINANCE ANNEX No. 384/2020 
15 
a) Reports of tests performed before hiring of the PCB. 
To take advantage of test reports conduced before hiring of the PCB, presented by the applicant in 
the initial documentation, the requirement 6.2.4.1.3 of this RAC must be fully met. 
 
b) Additional testing proposals. 
Proposals for additional tests submitted by the applicant must be analyzed by the PCB for possible 
inclusion in the product's Test Plan. The planning of the additional tests must contain, at a 
minimum, a clear definition of the test methods, number of samples and the acceptance / 
rejection criteria for eachof the tests. 
 
c) Responsibility and competence 
The PCB established in Brazil is responsible for the preparation of the Test Plan to be submitted to 
the laboratory. 
 
6.2.4.1.2 The Test Plan must be consolidated between the PCB and the Laboratory, before the 
beginning of the tests, and there must be interaction between both in order to enable and 
facilitate the execution of the tests or if a modification of the Initial Test Plan is necessary. 
 
6.2.4.1.3 The PCB must analyze, when submitted by the applicant, the reports of tests previously 
performed by the manufacturer. Test reports that meet the following requirement listed below 
can be accepted: 
a) The sample that was used for the tests described in the report must be traceable by the PCB in 
the manufacturer's design documentation. 
b) The tests contained in the Test Reports submitted by the applicant must meet the following 
requirements: 
i) The type test must have been carried out entirely in the pilot unit(s) or in the sample(s) of the 
equipment's production line in the certification process without changes. 
ii) for tests carried out by laboratories established in Brazil or not, the equivalence of the test 
method, the voltage and power supply frequency of the tested equipment must be observed. In 
addition, these laboratories must be accredited by Inmetro or by an Accreditation Body that is a 
signatory to a mutual recognition agreement of which Inmetro is also a part. 
iii) When applicable, the applicant must send a document stating that after the date of issue of the test 
report, the product has not been modified, in accordance with item A.1 of Annex A of this RAC. 
iv) The evaluation by the PCB of the tests performed on the initial equipment design; the risk 
management analysis of the product for which the report was issued; the updated equipment 
design; and the declaration of the previous item, when applicable, must integrate the 
documentation of the equipment certification process. 
v) The tests established in reports must include all the requirements of this RAC, and 
complementary tests or actions of the PCB or manufacturer are required when necessary. 
vi) For all types of equipment under health surveillance regimen, initial test reports and their 
complementary tests will be accepted, which validated design changes that may have occurred 
and that have a relevant impact on product safety, for the purpose of certification. 
vii) The PCB must evaluate and prove that the tested equipment is the same in the production 
line, and that the standards met are in compliance with the Anvisa Regulatory Instruction in force. 
viii) In the case of a product family, in accordance with Annex C of this RAC, the tests must have 
been carried out with a sample corresponding to the most critical configuration model (model that 
contains the largest number of requirements preestablished by the reference normative basis). 
The indication must be justified by the PCB. 
INMETRO ORDINANCE ANNEX No. 384/2020 
16 
ix) Other tests may be repeated, at the PCB's discretion, when nonconformities are identified in 
the tests that require corrective actions on critical components; or indicate that an uninformed 
and / or uncontrolled risk management design change has occurred. 
x) the PCB may require the applicant to present in the test report the measurement 
uncertainties when the result expressed (in the report) raises doubts to the PCB in relation to 
meeting a normative requirement. 
 
c) The testing laboratory(ies) contained in the Test Report(s) submitted by the applicant must 
comply with the requirement 6.2.4.3 “Laboratory Definition” of the GPCR. 
 
6.2.4.1.4 When applicable, the Test Plan must include additional parts, components or parts of 
the product complementary to the sample(s), which must receive the same treatment as 
requirement 6.2.4.2.1 to also be sent to the laboratory. 
 
6.2.4.1.5 The type tests must be repeated or complemented by the PCB assessment of the 
impact of changes in the mechanical or electrical-electronic design, or changes in the critical 
components, items 4.8 and 4.9 of the ABNT NBR IEC 60601-1 standard of the bill of materials of 
the product originally certified by the manufacturer, whenever this assessment concludes that 
revisions or modifications impact previously assessed compliance. 
 
6.2.4.2 Definition of Sampling 
 
6.2.4.2.1 For the performance of product evaluation tests, “technical model assessment” is 
applied, where the sample must be collected by the PCB or, by agreement between the parties, 
can be sent to the PCB or laboratory by the manufacturer. 
a) The sample(s) used in tests prior to the start of certification can be used in continuation and in 
new tests if the test report and existing records identify that the sample presented is identical to 
the one used for the tests until partial or final approval of the design. 
b) The sample must be composed of (1) one or more units of the finished products production 
line, released and packaged as for marketing or (1) one or more pilot units or series head or 
production line unit, when it is not in production. 
c) When applicable, the principle of selection and randomness of sample selection should be 
used, in accordance with ABNT NBR ISO / IEC 17025 and ABNT NBR ISO / IEC 17065. Deviations 
must be justified by the PCB without prejudice to the product assessment process. 
 
6.2.4.2.2 Either the applicant, when agreed with the PCB in accordance with requirement 
6.2.4.2.1 and under the guidance of the PCB, or the PCB, must prepare the Sample Report before 
sending it to the laboratory, characterizing and controlling its characteristics. The Sample Report 
must contain at least the following information: 
a) date of shipment of the sample; 
b) storage conditions; 
c) sample identification (model / brand / serial number or manufacturing batch); 
d) date of manufacture; 
e) manufacturing site; 
f) the sample must be sealed by the PCB or applicant, and must be sent to the laboratory 
accompanied with its report. 
 
6.2.4.2.3 The PCB, when the corrective action for any nonconformity(ies) identified during the 
INMETRO ORDINANCE ANNEX No. 384/2020 
17 
initial tests changes the design in a critical way that does not allow the continuation of the tests 
with the same sample, it must control the characteristics of the new sample(s) to be sent to the 
laboratory, in accordance with requirement 6.2.4.2. 
 
6.2.4.2.4 If the applicant considers, with the PCB, the evaluation of more than (1) one sample is 
necessary, the number of samples, acceptance / rejection criteria and exceptional cases must be 
negotiated with the applicant for a number greater than or equal to (3) samples. In this case, the 
following requirements of the GPCR apply: 
a) Table 4; and 
b) item 6.2.4.2.1. 
 
6.2.4.2.5 When applicable, additional parts, components or parts of the product complementary 
to the sample(s) must receive the treatment of requirement 6.2.4.2 to be sent to the laboratory 
together with the product. 
 
6.2.4.2.6 The laboratory must confirm and list in the test report all the documentation received 
necessary to carry out the tests, listed in item 6.2.1, as well as indicate their current versions 
whenever practicable. 
a) During the execution of the tests, the laboratory may question and request the PCB to review 
the test plan and the submitted documentation. 
b) The type test must be carried out entirely in the pilot unit or in the sample of the production 
line of the equipment in the certification process. 
 
6.2.4.2.7 The approval of the pilot unit or series head, in the initial tests, does not exempt the 
PCB from validating the products on the production line in the factory audit or, when deemed 
necessary, through tests. 
 
6.2.4.2.8 The tests must be carried out with the sample (s) submitted in accordance with that 
RAC. 
 
6.2.4.2.9 If the sample fails in the tests: 
a) If there is a non-compliance with a normative requirementthat does not prevent the 
performance or continuation of the tests, the laboratory continues the execution and informs the 
PCB of the deviation(s) identified through the test report. 
b) In the event of a failure of the equipment or failure to meet a regulatory requirement that 
prevents the equipment from operating or continuity of the tests respectively, the laboratory 
interrupts the activities and informs the PCB of the problem, so that it decides on: 
i) Authorize the laboratory to contact the applicant; 
ii) Inform the applicant to perform the maintenance of the equipment to continue the tests, or 
iii) Interrupt the tests and issuance of the test report. 
 
Note 1: The maintenance of the equipment consists of restoring the equipment back to its original 
characteristics for its correct operation. Maintenance does not include the implementation of 
corrective action(s) of the nonconformity(ies). 
Note 2: In case of loss of functionality of the equipment during the tests, the maintenance of the 
equipment is allowed with the authorization of the PCB for the continuity of the tests. 
c) Upon receiving the test report(s), the PCB issues report (s) with the analysis of the non-
conformity(ies). The decision to assess the nonconformity(ies) is the responsibility of the PCB. 
INMETRO ORDINANCE ANNEX No. 384/2020 
18 
 
6.2.4.2.10 It lies with the PCB to carry out a critical analysis of the laboratory test reports, by 
comparing them with the previously established test plan: 
a) The PCB, concluding that the sample failed the tests, must notify the nonconformity to the 
applicant. 
b) If the requester does not technically reply to the nonconformity(ies), this stage must be 
suspended and the requester must present a treatment plan with the elimination of the observed 
nonconformity(ies) for the restart of the tests defined as necessary by the PCB. 
c) From the analysis of the corrective action of the manufacturer or the test that failed the 
sample, the PCB can determine the replacement of the sample and repetition of tests. 
d) Among the corrective actions that may generate the need for repetition of tests is the 
alteration of critical component(s), which will lead to new tests. 
e) If the PCB determines the need to replace the sample(s) initially sent to the laboratory, the 
new sample(s) must be treated in the same way as requirement 6.2.4.2.1 before they are sent to 
the laboratory. 
f) The date for restarting the initial tests will be agreed between the applicant, PCB and the 
laboratory. 
 
6.2.4.2.11 Any alteration of critical component(s) must be reported to the PCB and will give rise 
to a critical analysis between the parties to determine the need for further testing. Failure to 
comply with this requirement invalidates the certification process, which must be suspended 
immediately if the PCB identifies the manufacturer's action. 
 
6.2.4.2.12 If the tests fail, and depending on the evaluation of the PCB, the sample must be 
considered failed and a new sample must be sent by the manufacturer to the laboratory. The PCB 
must control all the characteristics of the new sample. 
 
6.2.4.3 Definition of the laboratory 
For the purposes of this RAC, the laboratory's definition criteria must follow the prescriptions of 
the GPCR, amended or supplemented in accordance with this RAC: 
 
6.2.4.3.1 The requirement 6.2.4.3.1 of the GPCR applies in full, adding the following Note at 
the end of the Table: 
Note: Where it reads “provided in the RAC”, it refers to the tests provided for in the normative 
basis of the RAC. 
 
6.2.4.3.2 Requirement 6.2.4.3.2 of the GPCR applies with the following modifications: 
a) item “a” and Notes 1, 2, 3 and 4 apply in full; 
b) item “b” is entirely excluded and is replaced by the following text: 
When the laboratory (s) accredited by Inmetro / Cgcre or signatory to the mutual recognition 
agreements ILAC or IAAC, entirely within the specific scope does not meet (at) the maximum term 
of 4 (four) months for the beginning of the tests provided for in the RAC from the signing of the 
contract, in an exceptional and precarious character, the PCB can use laboratories in accordance 
with requirement 6.2.4.3.1 of the GPCR. For large equipment according to definition 4.7, this 
period extends to a maximum of 6 (six) months. 
c) item “c” is entirely excluded; and 
d) The accredited 3rd party laboratory has the prerogative to carry out tests in external 
locations in relation to the physical location of the laboratory, provided that it is clearly described 
INMETRO ORDINANCE ANNEX No. 384/2020 
19 
in the scope of accreditation its condition of being accredited for carrying out tests in the facilities 
external to the laboratory. 
 
6.2.4.3.3 Requirement 6.2.4.3.3 of the GPCR fully applies. 
 
6.2.4.3.4 Requirement 6.2.4.3.4 of the GPCR applies with the following modifications: 
In any of the cases of use of first-party laboratory accredited to the specific test scope, in whole or 
in part, the PCB must testify, record the execution of all tests, including monitoring the sample 
selection and preparation stage and taking of results. 
 
6.2.4.3.5 Requirement 6.2.4.3.5 of the GPCR applies with the following modifications: 
In any of the cases of use of 1st or 3rd party laboratory accredited for another test scope, the PCB 
must, after recognizing and registering the laboratory's qualification and infrastructure (including 
equipment), testify, record the execution of all tests, including monitoring of the sample selection 
and preparation stage and taking of results. 
 
6.2.4.3.6 Requirement 6.2.4.3.6 of the GPCR applies, by adding the following text: For 
compliance with the requirement of formal proof of experience, the PCB professional must have a 
record of participation in at least 3 (three) audits in the last three successive years, in the standard 
ABNT NBR ISO / IEC 17025: 2005 and evidence of knowledge, training and experience in the test to 
be evaluated and in the product to be tested. The formal audit training in the standard ABNT NBR 
ISO / IEC 17025: 2005 must be given by an organization independent from the PCB. 
 
6.2.4.3.7 Requirement 6.2.4.3.7 of the GPCR fully applies. 
 
6.2.4.3.8 If a single laboratory is not qualified for execution of all the planned tests, more than 
one laboratory can be used, obeying the prescriptions for laboratory selection of the GPCR 
complemented by this RAC. 
 
6.2.5 Treatment of nonconformities in the Initial Assessment stage 
Requirement 6.2.5 and items of “Treatment of nonconformities in the Initial Assessment stage” of 
the GPCR fully apply. 
 
6.2.6 Issuance of the Compliance Certificate 
The issuance of the Compliance Certificate must follow the conditions described in the GPCR and 
must be carried out by a family of equipment under a health surveillance regimen, as provided for 
in Annex C of this RAC. 
 
6.2.6.1 Critical Analysis and Certification Decision 
The requirement 6.2.6.1 and items of “Critical Analysis and Certification Decision” of the GPCR 
fully apply, complemented by the following requirements: 
 
INMETRO ORDINANCE ANNEX No. 384/2020 
20 
6.2.6.1.1 In the case of the certification of non-invasive measuring sphygmomanometers and 
digital clinical thermometers, which must meet metrological regulations, the certificate of 
conformity should only be granted to the applicant after obtaining the Model Approval Ordinance 
published by Inmetro. 
 
6.2.6.1.2 Test reports of the product for compliance with metrological requirements can be used 
in the certification process for this RAC if they duplicate any specific requirements for compliance 
assessment. 
 
6.2.6.1.3 The Compliance Certificate will not expire once maintenance activities are carried out. 
The maintenance of the certification is linked to the update of the DHF, execution of maintenance 
audits and complementary tests if there is a design change that critically affects the safety of the 
already certified Equipment and,consequently, that require complementary tests. 
Note: The maintenance of the certification is subject to compliance with the standards, in 
accordance with the Anvisa Regulatory Instruction in force. 
 
6.2.6.2 Certificate Issuance 
The requirement 6.2.6.2 “Issuance of the Certificate” of the GPCR fully applies: 
 
6.2.6.2.1 Requirements 6.2.6.2.1 and 6.2.6.2.2 of the GPCR fully apply. 
 
6.2.6.3 Compliance Certificate 
The requirement 6.2.6.3 “Compliance Certificate” of the GPCR fully applies: 
 
6.2.6.3.1 Requirement 6.2.6.3.1 of the GPCR applies, as per the items below: 
a) items “a”, “d”, “e”, “g”, “l” and “n” and Notes 1 and 2 apply in full; (specific for 
sphygmomanometers and digital thermometers) 
a) item “b” applies in full, replacing the term “applying supplier” with “applicant”, as defined in 
definition 4.20 of this RAC; 
b) item “c” applies in full, replacing the term “manufacturer” with “manufacturer, contract 
manufacturer, and / or legal manufacturer, when applicable”, respectively according to definitions 
4.8, 4.9 and 4.10 of this RAC; 
c) item “f” is applied in full, indicating “Model 5”; 
d) item “h” is fully applied, complementing with information on the original characteristics of the 
product; 
e) item “i” and “j” are entirely excluded; 
f) item “k” is fully applied, complementing with the identification of the technical standards 
applied in the certification; 
g) item “m” is fully applied, complementing with the information of the date(s) of issue of the 
test report(s); 
h) inform the date of acceptance of the proposal; 
i) inform the list of accessories and parts tested together with the product; 
j) inform the version of the user manual and the product design evaluated for the concession of 
the certification; and 
k) inform the version of the evaluated software, for equipment with embedded software or that 
accompanies it. 
 
 
INMETRO ORDINANCE ANNEX No. 384/2020 
21 
6.3 Maintenance Assessment 
The Maintenance Assessment must be performed by the PCB, according to the conditions 
established by the GPCR, in annexes A and B of this RAC. Notes 1, 2 and 3 of requirement 6.3 of 
the GPCR are excluded from this RAC. 
 
6.3.1 Maintenance Audit of the Quality Management System, Risk Management and 
Productive Process of the Manufacturer. 
The maintenance audit must be performed by the PCB, according to the conditions established in 
the GPCR, and in annexes A and B of this RAC with the following changes: 
 
6.3.1.1 Requirement 6.3.1.1 of the GPCR applies replaced by: 
 
6.3.1.1.1 The PCB should schedule the periodic maintenance audit to be carried out in the 
manufacturer's production process or in the service provider contemplating, at least, the following 
stages: 
a) verification of the original copies of the documentation provided for in item 6.2.1, in particular 
regarding their availability, organization and recovery; 
b) analysis of the records, especially those related to compliance with the requirements for 
carrying out the audits listed in Annexes A and B of this RAC; and 
c) the PCB must evaluate, during the audit of companies with a production process considered 
essential to the manufacture of the product object to this certification, if these companies adopt a 
Quality Management System certified in accordance with ABNT NBR ISO 13485: 2016 or Anvisa 
RDC No. 16 / 2013 “Certificate of Good Manufacturing Practice”: 
i) that the latest audit report for the product object by this certification covers the requirements 
provided in Annex B and that these are in compliance; 
ii) that in both cases, the certificate is valid; and 
iii) that the general verification items in Annex A of this RAC have been satisfied. 
d) Alternatively, compliance with item c) can be carried out through the audit reports issued 
within the scope of the Unified Health Products Audit Program (MDSAP in Portuguese for 
Programa de Auditoria Única em Produtos para a Saúde). 
 
6.3.1.2 Requirement 6.3.1.2 of the GPCR applies by replacing the term "Inmetro/Dconf" with 
“Anvisa”. 
 
6.3.1.3 The PCB must witness the performance of routine tests on the production line whenever 
applicable. Alternatively, the records of tests performed can be used to provide evidence of 
compliance with this requirement. 
 
6.3.1.3.1 The audit must be done in agreement between the PCB and the manufacturer. The RCB 
should schedule the plant audit preferably for the period in which the production line is operating. 
 
6.3.1.3.2 When witnessing the operation of the production line and the performance of 
functional and routine tests, when applicable, as scheduled, the PCB must record the serial 
number and model of the product evaluated in the face-to-face tests. 
 
6.3.1.4 If it is not possible for the PCB to witness the operation of the assembly line even during 
the maintenance audit, the records of tests already carried out can be used to provide evidence of 
compliance with this requirement. 
INMETRO ORDINANCE ANNEX No. 384/2020 
22 
6.3.1.5 Provided that there is evidence to justify it or as instructed by Anvisa, the PCB can carry 
out extraordinary maintenance audits and type tests for verification of compliance maintenance of 
the certified products. 
 
6.3.1.6 The periodicity of maintenance audits cannot be greater than 15 (fifteen) months, 
counting from the date of issue of the certificate. 
 
6.3.2 Maintenance Test Plan 
Requirement 6.3.2 of the GPCR applies, which is complemented and modified below. The 
establishment of the Maintenance Test Plan may occur through determination of the PCB, based 
on the audit in accordance with Annex A, due to design changes that may critically affect the 
safety of the product and that have been identified in audits and have not been informed by the 
manufacturer or applicant to the PCB or when there is an update in the ANVISA regulations that 
establish the technical standards applicable to the compulsory certification and that require the 
execution of new tests, or through determination of Anvisa. Under these conditions, the 
Maintenance Test Plan must follow the prescriptions of the complemented by this RAC. 
 
Note 1: The Maintenance Test Plan does not apply to factory tests, previously agreed between PCB 
and the manufacturer, in accordance with the RMF and Annexes A and B of that RAC whenever 
applicable. 
 
Note 2: The definition of when the measurement uncertainty values are relevant within the 
certification process is the responsibility of the PCB. When test reports issued by accredited 
laboratories are used, where the uncertainty values are not mentioned, without prejudice to the 
certification process, the PCB should be able to technically justify the absence of the measurement 
uncertainty values. 
 
6.3.2.1 Definition of tests to be performed 
When applicable, maintenance tests must be carried out in accordance with the requirements of 
item 6.2.4.1 of the GPCR, observing the Anvisa Normative Instruction in force complemented by 
this RAC. 
 
6.3.2.2 Definition of maintenance sampling 
The criteria for Definition of Sampling in Maintenance Assessment must follow, together with the 
prescriptions established in the GPCR, the following requirements: 
 
6.3.2.2.1 The collection of samples, by family, according to Annex C of this RAC, must include 
the most critical configuration model. 
 
6.3.2.2.2 The minimum of (1) one sample must be collected from the production line, by 
random selection carried out by the PCB, of products already inspected, released and packaged for 
marketing. 
 
6.3.2.3 Definition of the laboratory 
The laboratory's definition criteria, if changes in the product were identified during the 
certification maintenance audit, must follow, together with the prescriptions of the GPCR, the 
same requirements of item 6.2.4.3 of this RAC. 
 
6.3.3 Treatment of nonconformities in the Maintenance stage 
INMETRO ORDINANCE ANNEX No. 384/2020 
23 
The criteria for the treatment of nonconformities in the maintenance stage mustfollow the 
prescriptions of the GPCR, complemented by the instructions of this RAC. 
 
6.3.3.1 If rejection of the sample occurs during execution of the tests in item 6.3.2.1, the 
nonconformity must be notified to the applicant and the Compliance Certificate will be suspended. 
If the applicant does not technically reply to the nonconformity within 15 days, the applicant must 
submit a treatment and elimination plan for the observed nonconformity(ies) for the restart of the 
tests defined as necessary by the PCB, from analysis of the manufacturer's corrective action. A 
new sample must be taken in accordance with requirement 6.3.2.2 of this RAC and new tests must 
be conducted. 
 
6.3.3.2 If rejection occurs during execution of the maintenance tests of item 6.3.2.1, the 
rejected products, which are in the applicant's possession, must be treated as nonconforming 
products according to the requirements of Anvisa RDC regulation 16/2013 or its substitutive 
regulation. 
 
6.3.3.2.1 This decision must be duly grounded to ensure that nonconforming products or 
products with compromised safety are not placed in the market. 
 
6.3.3.3 As the nonconformities confirmed during the maintenance tests are remedied, the PCB 
must evaluate the need for execution of new tests according to item 6.2.5 of this RAC. 
 
6.3.3.4 The PCB must inform Anvisa, through the email certifica.eletromedicos@anvisa.gov.br, about 
the nonconformities identified in the certification maintenance process, which require a field action or 
recall, whenever there are sufficient evidences or proof that a health product does not meet the applicable 
essential safety and efficacy requirements. The following information about the identified product 
and problem must be included in the e-mail: 
a) description of the problem; 
b) trade name and product model; 
c) batches / series under risk; 
d) the registration number with Anvisa; 
e) name of the applicant holder of the certificate; 
f) The risk related to the use of the product; and 
g) corrective actions related to the product / problem. 
 
6.3.3.5 With the monitoring of the PCB, the certification holder must initiate a field action, 
complying with the terms of RDC 23/2012 or substitutive resolution, whenever there is sufficient 
evidences or proof that a health product does not meet the applicable essential safety and efficacy 
requirements. 
 
6.3.4 Confirmation of Maintenance 
The criteria for confirmation of certification maintenance must follow the prescriptions of the 
GPCR, complemented by the instructions of this RAC. 
 
6.3.4.1 The PCB must inform Anvisa about the cancellation or suspension of the certificate through the 
email certifica.eletromedicos@anvisa.gov.br containing the following information: 
a) Certificate number and PCB number; 
b) Applicant's name; 
c) Product brand and model; 
 
mailto:certifica.eletromedicos@anvisa.gov.br
mailto:certifica.eletromedicos@anvisa.gov.br
INMETRO ORDINANCE ANNEX No. 384/2020 
24 
d) Anvisa regularization number; and 
e) A report of the reason for the cancellation or suspension, with the report number when 
applicable. 
 
 
7 HANDLING OF COMPLAINTS 
The criteria for handling of complaints must follow the prescriptions, of the GPCR, complemented 
by this RAC. 
 
7.1 Requirement 7, “Handling of Complaints”, of the GPCR applies fully complemented by: 
 
7.2 The PCB must perform audits with a maximum interval of 15 months, on the applicant, 
conducted to assess compliance with requirement 7 of the GPCR; and 
 
7.3 The applicant must ensure that complaints are forwarded to the manufacturer and that the 
manufacturer's responses are sent to the customer; 
 
7.4 The applicant must have a complaint handling process that complies with requirement 7 of 
the GPCR, expressed in the form of a documented procedure inserted in the Quality Management 
System. 
 
 
8 ACTIVITIES EXECUTED BY PCB ACCREDITED BY IAF MLA MEMBER 
The criterion "Activities Executed by PCB Accredited by IAF MLA Member" must follow the 
prescriptions of the GPCR. 
 
 
9 TRANSFER OF CERTIFICATION 
The criterion “Transfer of Certification” must follow the prescriptions of the GPCR. 
 
9.1 The transfer of certificates is authorized due to the applicant's dissatisfaction with the 
performance of the Product Certification Body responsible for the issuance of the certificate, 
provided that the following conditions are observed: 
a) All requirements of item 9, “Transfer of Certification” of this RAC must be complied with. 
b) Only the transfer of certificates that are not suspended, canceled and that on the request 
date of the transfer, have no pending issues or nonconformities identified by the responsible PCB, 
ANVISA or INMETRO, or that may be in suspension or cancellation processes in progress and other 
conditions established in requirement 9 of the GPCR. 
c) In situations whose suspension or cancellation is related to the suspension or cancellation of 
PCB accreditation, the transfer of certificates and certification processes in progress from one PCB 
to another will be allowed, taking as a technical basis what was established on the date of 
requesting the contract with time. 
 
 
10 CLOSURE OF CERTIFICATION 
 
INMETRO ORDINANCE ANNEX No. 384/2020 
25 
10.1 In the event of closure of the certification, which may be due to the closure of the 
manufacture / importation of the certified products or, at the option of the certificate holder, in 
the case of voluntary certification, the PCB shall ensure that the objects certified prior to this 
decision are in compliance with the requirements set out in this RAC. 
 
10.2 Therefore, if deemed necessary, the PCB can schedule audits, which can be remote, carry 
out tests or simply analyze the most recent records of follow-up tests carried out by the 
manufacturer responsible for the production chain. 
 
10.3 If any nonconformity is evidently seen, the PCB, before considering the process closed, 
must request from the certificate holder the relevant treatment, defining the provisions and the 
deadlines for implementation. 
 
10.4 The OCP must notify the closure of the certification to Anvisa through the email 
certifica.eletromedicos@anvisa.gov.br with the following information: 
a) certificate number and PCB number; 
b) applicant's name; 
c) product brand and model; 
d) Anvisa regularization number; 
e) attach the reason for the closure; and 
f) possibility of existence of nonconforming product on the market. 
 
10.5 The results of the audit, tests and closure records must be documented to integrate the 
documentation of the product certification process and must be maintained by the PCB in 
electronic or other media for at least 5 years from the closing date of the certification. 
 
10.6 In the case of compulsory certification, from the end of certification, the product can no 
longer be manufactured, and the importation, distribution and marketing of the stock produced 
within the validity of the certification is admitted, with no time limit to exhaust the stock, provided 
that it complies with ANVISA Regulations. 
 
 
11 COMPLIANCE IDENTIFICATION SEAL 
The "Compliance Identification Seal" criterion must follow the prescriptions of the GPCR, 
complemented by the instructions of this RAC: 
 
11.1 Requirement 11.1 of the GPCR applies fully. 
 
11.2 Requirement 11.2 of the GPCR applies, by replacing it with the following text: 
The Compliance Identification Seal can be printed on the Compliance Certificate, and must be 
marked or affixed to the product and/or printed or affixed to the packaging, in accordance with 
the instructions of Annex II - Compliance Identification Seal, of this Ordinance. 
 
11.3 Requirement 11.3 of the GPCR applies, by replacing it with the following text: 
In the case of imported products, the Conformity Identification Seal must be marked or affixed to 
the product and / or printed or affixed to the packaging, in accordance with the instructions of 
Annex C, Conformity Identification Seal,