G/TBT/N/BRA/756  
 
8 November 2017  
(17-6054) Page: 1/6 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: BRAZIL   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: Brazilian Health Regulatory Agency (Anvisa)  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Medical 
Devices  
5. Title, number of pages and language(s) of the notified document: Resolution - RDC 
n. 183, October 17th, 2017. Portuguese – Good Manufacturing Practices Certificate to 
manufacturers of Medical Devices.   
6. Description of content: This Resolution provides for inspection programs and 
administrative procedures to grant of Good Manufacturing Practi ces Certificate to 
manufacturers of Medical Devices located outside the Brazilian territory and Mercosur.  
CHAPTER I  
 INITIAL PROVISIONS  
Section I  
Objective  
Article 1 This Resolution provides for inspection programs and establishes procedures to 
grant of Go od Manufacturing Practices Certificate to manufacturers of Medical Devices 
located outside the Brazilian territory and Mercosur, as a complement to the provisions of 
Collegiate Board Resolution – RDC no. 39 of 14 August 2013.  
 
Section II  
Scope  
Article 2 This Resolution applies to the grant of Medical Devices Good Manufacturing 
Practices Certificate to manufacturers located outside the Brazilian territory and Mercosur.  
Sole paragraph. In order to assess compliance with the Good Manufacturing Pra ctices by 
means of inspection programs, the guidelines established by this Resolution may extend to 
Brazilian manufacturers, as well as the manufacturers located in the other Mercosur 
countries.  
 G/TBT/N/BRA/756  
 
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  Section III  
Definitions  
Article 3 For the purposes of this Resolution, the following definitions are adopted:  
I – finished device: the product, being one, a family, a system, or a set of products, which 
is ready for use or functionally complete, whether it is packed, labeled, or  sterilized, or 
not;  
II – manufacturing site: the establishment where product manufacture or manufacturing 
stage occurs, and it may be the legal manufacturer, contracted manufacturer, or the 
Original Equipment Manufacturer – OEM. 
 
CHAPTER II  
PETITION DOCU MENTS  
Article 4 All Good Manufacturing Practices Certification processes provided in this 
Resolution shall contain the following documents:  
I – duly completed specific petition form for the Certification of Medical Devices Good 
Manufacturing Practices in  other countries;  
II – proof of payment, or exemption, of the Taxa de Fiscalização de Vigilância Sanitária – 
TFVS (Health Surveillance Inspection Fee), using a specific Guia de Recolhimento da União 
– GRU (official federal payment document);  
III – quality manual of the manufacturing site undergoing the certification process;  
IV – list of all products being manufactured by the manufacturing site undergoing the 
certification process, with an indication of the products that are or will be exported to 
Brazil;  
V – general production flowchart of the products manufacturing processes, with the 
identification of which stages are performed at the manufacturing site undergoing the 
certification process;  
VI – layout of the manufacturing site undergoing the certificati on process, including plant 
floor plans;  
VII – copy of a valid conformity certificate (in the case of electromedical equipment), 
issued by the certifying body, when applicable;  
VIII – list of all inspections or regulatory audits of the manufacturing site u ndergoing the 
certification process for the last 3 (three) years, with an indication of the period of each 
inspection or audit; name of the health authority or third party auditing organization 
responsible for its execution; conclusion and details of any c onsequent regulatory action;  
IX – statement indicating in which countries the products that are or will be exported to 
Brazil are authorized, with the respective authorization documents;  
X – copy of the latest inspection or audit report issued by the heal th authority from the 
country of origin or by a third party auditing organization recognized by the health 
authority;  
XI – copy of the latest inspection or audit report issued by the health authority in an 
International Medical Device Regulators Forum (IM DRF) member country or by a third 
party auditing organization recognized by the health authority, when applicable; and  
XII – copy of the latest audit report issued by a third party auditing organization 
recognized by Anvisa, when applicable.  
Sole paragraph. The document protocol shall comply with the provisions in RDC no. 25, of 
16 June 2011, and its updates.  
Article 5 The manufacturing site undergoing the certification process may send the 
documents referred to in items VIII to XII of Article 4 di rectly to Anvisa, as long as the 
documents are duly identified and in addition to the related dossier.  
Sole paragraph. The manufacturing site shall register the documents referred to in the 
caption of this article in up to 30 (thirty) days after the certi fication petition is registered.   
 
CHAPTER III  
MANUFACTURING SITES SUBJECT TO GOOD MANUFACTURING PRACTICES 
CERTIFICATION  
Article 6 The following manufacturing sites are subject to Good Manufacturing Practices 
Certification for the purposes of authorizatio n, authorization renewal, or change (inclusion 
or alteration) of medical devices manufacturer at Anvisa:  
I – Manufacturing  site that makes a finished device in its name or for another company ; 
II – Manufacturing site that is responsible for releasing the finished device, related to at 
least one production stage, except for designing, distribution, sterilization, packing, and 
labeling stages; and  G/TBT/N/BRA/756  
 
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  III – Manufacturing site of Software as a Medical  Device – SaMD.  
Sole paragraph. Anvisa shall not issue a Good Manufacturing Practices Certificate to 
manufacturing sites not provided for in this article.  
 
CHAPTER IV  
INSPECTION PROGRAMS   
Article 7 Anvisa shall assess the compliance with the Medical Device s Good Manufacturing 
Practices by the manufacturers located outside the Brazilian territory and Mercosur through 
specific inspection programs, as a priority.  
Paragraph 1 The programs referred to in the caption of this article relate to a set of actions 
carried out for the purposes of inspection in manufacturing sites of products authorized by 
Anvisa.  
Paragraph 2 The programs shall occur regardless of certification processes.  
Paragraph 3 The programs shall be defined according to a health risk assessment 
considering the intrinsic risk of products, the complexity of manufacturing processes, 
technologies involved, and background data of inspection, monitoring, and authorization of 
products.  
Paragraph 4 The inspection programs may be extensive to Brazilian m anufacturers and 
those located in the other Mercosur member countries.  
Paragraph 5 The programs shall be planned considering the Agency 's operational capacity 
to carry out inspections, as well as assessed, reviewed, and published yearly.  
Paragraph 6 The audit reports issued within the framework of the Medical Device Single 
Audit Program (MDSAP) shall also be used to assess the compliance with the Good 
Manufacturing Practices through the programs referred to in this chapter.  
 
CHAPTER V  
GRANT OF GOOD MANUFACTURING PRACTICES CERTIFICATES  
Section I  
General Provisions  
Article 8 The grant of Good Manufacturing Practices Certificate of Medical Devices of risk 
classes III and IV may occur through one of the following, after document assessment :  
I – on presentation of a valid audit report, issued by a third party auditing organization, in 
accordance with specific programs, both recognized by Anvisa ; 
II – using confidential information on inspections, received under Agreements or 
Covenants with health authorities of other countries;  
III – by assessing inspection or audit report issued by the health authority of an IMDRF 
member country, or by a third party auditing organization recognized by the health 
authority;  
IV – by assessing an audit report issued by a third party auditing organization recognized 
by Anvisa;  
V – by making a risk analysis to assess the need for in loco inspection before granting the 
Good Manufacturing Practices Certificate, in the case of petitions not referred to or which 
do not comply with the requirements established for items I to IV above.  
 
Section II  
On the grant of the Good Manufacturing Practices Certificate on presentation of a 
valid audit report issued by a third party auditing organization, in accordance 
with specific  programs, both recognized by Anvisa  
Article 9 The Good Manufacturing Practices Certificate shall be granted to the 
manufacturers participating in the Medical Device Single Audit Program (MDSAP), after an 
assessment of the audit report presented in accordance with the guidelines established b y 
the Program.  
Section III  
On the grant of the Good Manufacturing Practices Certificate using confidential 
information  
Article 10 Anvisa may grant the Good Manufacturing Practices Certificate using confidential 
information on inspections, received under A greements or Covenants with health 
authorities of other countries, after mutual recognition.  
Sole paragraph. The guidelines and requirements to grant the Good Manufacturing 
Practices Certificate based on the provisions in the caption of this article shall  be 
established under each Agreement or Covenant.  
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  Section IV  
On the grant of the Good Manufacturing Practices Certificate by assessing reports 
issued by the health authority of an IMDRF member country, by a third party 
auditing organization recognized by  the health authority, or by a third party 
auditing organization recognized by Anvisa  
Article 11 Anvisa may grant the Good Manufacturing Practices Certificate in the hypotheses 
of items III and IV of Article 8 under the following conditions:  
I – by assess ing the inspection or audit report presented in accordance with item XI of 
Article 4; or  
II – by assessing the inspection or audit report presented in accordance with item XII of 
Article 4.  
Paragraph 1 The inspection or audit report referred to in items I  and II of this article shall 
comply with the guidelines of the document IMDRF/MDSAP WG/N24 FINAL: 2015 - Medical 
Device Regulatory Audit Reports  and its updates.  
Paragraph 2 The inspection or audit report shall have been issued in up to 2 (two) years 
prior to the date of protocol, include risk classes and production lines that are subject to 
the certification petition, and allow for the conclusion that the manufact uring site complies 
with the good manufacturing practices.  
Section V  
On the grant of the Good Manufacturing Practices Certificate for cases not 
referred to in the previous sections above  
Article 12 In the occurrence of petitions not referred to, or which do not comply with the 
requirements in Sections II, III, or IV of this Chapter, Anvisa shall make a risk analysis to 
assess the need for in loco  inspection before granting the Good Manufacturing Practices 
Certificate.  
Paragraph 1 The risk analysis shall be  carried out based on a risk matrix previously defined 
by Anvisa, which considers the result of document assessment referred to in Article 4, the 
complexity of the manufacturing site, technologies involved, the intrinsic risk of products, 
and indication of  use. 
Paragraph 2 In the occurance of manufacturing sites  previously certified by Anvisa, the risk 
analysis referred to in the caption of this article shall also consider:  
I – the history of compliance with the Good Manufacturing Practices by the manufacturing 
site undergoing the  certification process, obtained by Anvisa from its database;  
II – the history of proven deviations, technical complaints, adverse events, field ac tion 
notifications, and/ or health infractions proven by competent authorities, obtained by 
Anvisa from its database;  
III – time period since the last inspection; and  
IV – status of product authorization.  
Paragraph 3 The risk analysis may also indicate an in loco  inspection of reduced scope.   
 
CHAPTER VI  
TRANSITIONAL PROVISIONS  
Article 13 There shall be a transition period between the current form of action and the one 
provided for in this Resolution to assess the compliance with the Medical Devices Good 
Manufacturing Practices by the manufacturers located outside the Brazilian territory and 
Mercosur.  
Article 14 The companies that did not have an international inspection scheduled or carried 
out by Anvisa shall present:  
I – the documents referred to in Arti cle 4 that have not been presented yet;  
II – formal statement if the company is or is not still interested in being granted the Good 
Manufacturing Practices Certificate.  
Paragraph 1 The document presentation referred to in items I and II of this article shall 
occur as an addition to the initial certification dossiers, in up to 60 (sixty) days from the 
date this Resolution is published.  
Paragraph 2 The certification petiti ons not including the documents referred to in items I 
and II of this article, within the period of time established, are subject to rejection.  
Paragraph 3 In the cases where companies present a formal statement of withdrawal of 
petitions not assessed yet by Anvisa, the matters related to reimbursement of fees shall be 
dealt with directly at Anvisa 's Gerência de Gestão de Arrecadação  – Gegar  (Collection 
Management Office).  
Article 15 Anvisa will take exceptional and transitional measures aiming at granting Medical 
Devices Good Manufacturing Practices Certificates to manufacturing sites located in other G/TBT/N/BRA/756  
 
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  countries, the petitions of which (subject co de 8331 and 8079) were registered until the 
date this Resolution is published.  
Paragraph 1 For petitions of manufacturers that currently take part in the Canadian 
Medical Devices Conformity Assessment System – CMDCAS, and will move to the Medical 
Device S ingle Audit Program (MDSAP), a valid proof of participation in the CMDCAS 
program shall be presented within 60 (sixty) days in order to show the company is 
compliant with its requirements.  
Paragraph 2 For petitions of manufacturers that have been audited by a third party 
auditing organizations recognized by Anvisa, an audit certificate or report stating the 
compliance with the Good Manufacturing Practices, issued by the auditing organization, 
shall also be presented within 60 (sixty) days, and include in i ts scope the manufacturing 
stages, risk classes, and the production lines of the products in the certification petition.  
Article 16 The petitions referred to in Articles 14 and 15 shall be analyzed after 60 (sixty) 
days from the date this Resolution is pu blished.  
Sole paragraph. Analysis of the dossiers shall observe the initial chronological order of 
petition entry.  
Article 17 Anvisa shall assess the compliance with the requirements in Article 4, 14, and 
15, and the grant of Good Manufacturing Practices  Certificates to petitions registered by 
the date this Resolution is published may occur, on an exceptional basis, as follows:  
I – on presenting a document stating that the manufacturing site undergoing the 
certification process participates in the CMDCAS program and also meets its requirements;  
II – on presenting an audit certificate or report issued by an auditing organization 
recognized by Anvisa, which states the compliance with the Good Manufacturing Practices 
by the manufacturing stages, risk classes , and production lines undergoing the certification 
petition; or  
III – on carrying out a risk analysis to assess the need of an in loco  inspection before 
granting the Good Manufacturing Practices Certificate, in the case of petitions not referred 
to, or n ot meeting the requirements established in the previous items.   
Article 18 If the third party auditing organization working within the CMDCAS program is 
not recognized by the Medical Device Single Audit Program (MDSAP) in the future, Anvisa 
may reassess th e grant of certificates cerissued in accordance with the provisions in Article 
17.  
Article 19 In the period of 60 (sixty) days established for the addition of documents to the 
initial certification dossiers, the international inspection schedule shall be maintained, 
based on the criteria established before this Resolution is published.  
Sole paragraph. Requests to alter inspection dates agreed upon by the parties and already 
approved by Anvisa 's competent office shall not be approved, and the refusal to me et the 
date initially scheduled shall result in the petition 's rejection.  
Article 20 Anvisa 's Health Inspection Office (GGFIS) shall notify the Medical Devices 
Technology Office (GGTPS) about all rejections and requests of withdrawal from the Good 
Manufacturing Practices Certification occurring during the transition period referred to in 
this chap ter.  
 
CHAPTER VII  
FINAL PROVISIONS  
Article  21 The certification petitions not containing the documents required at the moment 
of presentation, or petitions with unsatisfactory result of the technical analysis, are subject 
to rejection.  
Article  22 The cer tification issued based on the documents provided for in articles 9, 10, 
11, and 12 does not exempt the company from receiving an in loco  inspection by Anvisa, 
at any time, even during the validity of the Good Manufacturing Practices Certificate of 
which w as granted, and the company may not refuse to receive the inspection.  
Paragraph  1 The refusal to receive the inspection referred to in the caption of this article 
will cause the precautionary suspension of the certificate until the inspection is concluded  
and its report is issued, stating the compliance with the Good Manufacturing Practices is 
satisfactory.  
Paragraph  2 The refusal referred to in the caption of this article will also cause the opening 
of health administrative proceedings against the compan y that requested the certificate; 
import and commercialization may be suspended, and the products involved may be 
deemed subject to withdrawal.  
Article 23 The refusal to receive inspections planned under the programs, regardless of the 
company being certi fied or not by Anvisa, will cause the opening of health administrative G/TBT/N/BRA/756  
 
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  proceedings against the authorization holder in Brazil; import and commercialization may 
be suspended, and the products involved may be deemed subject to withdrawal.  
Article  24 This Re solution revokes Article 2 of RDC no. 179 of 27 September 2017, 
published on the Federal Official Gazette of 2 October 2017.  
Article 25 This Resolution enters into force on the date of its publication.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº 201,19 
October 2017, section 1, pages 27/28; (2) Law Nº 9782, 26 January 1999; Resolution – 
RDC no. 61 of 3 February 2016 (3) Brazilian Official Journal; (4) Not Aplicable.   
9. Proposed date of adoption:  On the date of its publication  
Proposed date of entry into force:  On the date of its publication  
10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa ) 
SIA, Trecho 5, Área Especial 57  
Brasília – DF / Brazil  
CEP: 71.205 -050  
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/3612364/%281%29RDC+n%C2%BA+183+
-+2017 -+english +version.pdf/dfeca3e7 -8c83-43c1-bc41-0fa8ccafa5a7