G/TBT/N/BRA/1500  
11 September 2023  
(23-5995) 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 
1200, 01 Septemb er 2023; (6 page(s), in Portuguese)  
6. Description of content:  This Draft Resolution contains provisions on the establishment 
of an optimized procedure for the analysis and decision of requests for registration of 
medical devices, through the use of analy zes carried out by an Equivalent Foreign 
Regulatory Authority.  
For the purposes of adopting the optimized analysis procedure, the following AREE 
andrespective proof of registration or authorization:  
I - Australia: Australia Therapeutic Goods Administration (TGA) – Australian Register of 
TherapeuticGoods (ARTG);  
II - Canada: Health Canada (HC) – Medical Device License;  
III - Japan: Japan Ministry of Health, Labor and Welfare (MHLW) – Pre-market approva l 
(Shonin) fromMHLW; It is  
IV - United States of America (USA): US Food and Drug Administration (US FDA) – 
510KClearance or Premarket Approval (PMA).  G/TBT/N/BRA/1500  
 
- 2 - 
 
  7. Objective and rationale, including the nature of urgent problems where 
applicable:  This draft resoluti on aims at providing instruments for the construction 
process of regulatory trust with other Foreign Regulatory Authorities, in addition to being 
convergent with international practices and promotes the use of tools for mutual 
recognition of processes medi cal device regularization toilets.; Protection of human health 
or safety  
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:  25 September 2023; The short comment period occurs 
because it is a low regulatory impact norm.  
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/10181/6649665/consulta_+publica_1200_2023
+SGCOL+DP+.pdf/2c4f52c 0-762f-4028-b17f-c4aa621e1ef6  Comment form: 
https://pesquisa.anvisa.gov.br/index.php/922864?lang=pt -BR The comment form link 
will be available only on 11 September 2023.  
https://members.wto.org/crnattachments/2023/TBT/BRA/23_12219_00_x.pdf