  
  
G/TBT/N/BRA/1297  
7 January 2022  
(22-0189) 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   
Website: www.inmetro.gov.br/barrei rastecnicas  
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):  HS 
(3006); Pharmaceutical preparations and products of subheadings 3006.10.10 to 
3006.60.90 (HS 3006)  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 591, 21 December 2021 (12 page(s), in Portuguese)  
6. Descri ption of content:  This resolution contains provisions on the identification of 
regularized medical devices at Anvisa, through the Unique Device Identification (UDI) 
system.  
7. Objective and rationale, including the nature of urgent problems where 
applicab le: Protection of human health or safety  
8. Relevant documents:   
9. Proposed date of adoption:  10 January 2022  
Proposed date of entry into force:  10 January 2022  
10. Final date for comments:  Not applied  G/TBT/N/BRA/1297  
 
- 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  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://antigo.anvisa.gov.br/documents/10181/6292482/RDC _591_2021_.pdf/90a75ad5
-1071-4f19-b336-ab1dcc9b2763  
 