G/TBT/N/BRA/1506  
19 October 2023  
(23-7043) Page: 1/2 
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 2145.3817  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.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 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
equipment (ICS code(s): 11.040)  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
1208, 16 October 2023; (2 page(s), in Portuguese)  
6. Description of content:  This draft resolution proposes changes to administrative 
procedures for granting Good Practices Certification Manufacturing and Certification of 
Good Distribution and /or Storage Practices, to enable the increase in the validity period 
of certificates of good manufacturing practices (CBPF) of medical device manufacturers 
granted through the Medical Device Single Audit Program - MDSAP.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The increase in the validity period of CBPFs from medical device 
manufacturers granted through the MDSAP program aims to reduce the regulatory cost 
for companies and increase adherence to  the MDSAP program, thus reducing Anvisa's 
certification liability and the number of national and international meetings carried out by 
the National health surveillance system (SNV), so that Anvisa and SNVS can direct their 
resources to higher risk actions . Furthermore, increasing the number of companies 
participating in the program would represent an increase in the number of companies that 
receive annual monitoring, for which Anvisa receives updated reports from Auditing 
Bodies, thus reducing the risk ass ociated with the manufacturing of the respective medical 
devices.; Protection of human health or safety  G/TBT/N/BRA/1506  
 
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  8. Relevant documents:   
- 
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  8 December 2023  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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  
The final text is available only in Portuguese and can be downloaded at:  
Draft: 
http://antigo.anvisa.gov.br/documents/10181/6668081/consulta+_publica_1208_2023
+SGCOL+DP+.pdf/bd6c874d -f7df-480b-8d80-290350ea5b62  Comment form: 
https://pesquisa.anvisa.gov.br/index.php/872368?lang=pt -BR The link of the comment 
form is going to be available only on 25 October 2023.  
https://members.wto.org/crnattachments/2023/TBT/BRA/23_13055_00_x.pdf