  
  
G/TBT/N/BRA/1311  
15 March 2022  
(22-2269) 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 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Medical 
devices (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Resolution 
number 608, 25 February 2022 (19 page(s), in Portuguese)  
6. Description of content:  This reso lution contains provisions on the compassionate use 
of medical devices.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health.; Protection of human health or safety  
8. Relevant documents:   
9. Proposed date of adoption:  2 March 2022 ; On the date of its publication  
Proposed date of entry into force:  2 March 2022 ; On the date of its publication  
10. Final date for comments:  Not applied  G/TBT/N/BRA/1311  
 
- 2 - 
 
  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  
ZIP CODE: 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:  
http://antigo.anvisa.gov.br/documents/10181/6279684/RDC_608_2022_.pdf/eaee78b3
-9f0a-416c-9632-05de32458ed8  
 
The Annexes I, II, III, and IV of this resolution were republished:  
https://www.in.gov.br/en/web/dou/ -/resolucao -rdc-n-608-de-25-de-fevereiro -de-2022-
383575805  
 
http://ant igo.anvisa.gov.br/documents/10181/6279684/RDC_608_2022_.pdf/eaee78b3
-9f0a-416c-9632-05de32458ed8  
https://www.in.gov.br/en/web/dou/ -/resolucao -rdc-n-608-de-25-de-fevereiro -de-2022-
383575805  
 