G/TBT/N/BRA/1081  
6 October 2020  
(20-6809) 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):  
Provitamins and vitamins, natural or reproduced by synthesis (including natural 
concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the 
foregoing, whether or not in any  solvent (HS 2936); Hormones, natural or reproduced by 
synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily 
as hormones (HS 2937); Pharmaceutical products (HS 30)  
5. Title, number of pages and language(s) of the notifi ed document:  Resolution – 
RDC number 423, 16 September 2020. (9 page(s), in Portuguese)  
6. Description of content:  This Resolution changes the Resolution – RDC number 27, 
21 June 2011, the Resolution – RDC number 36, 26 August 2015, and the Resolution – 
RDC number 40, 26 August 2015; and establishes the cancellation of the registration 
system for medical devices classified as Risk I and II classes, which must be registered 
in the notification regime.  
7. Objective and rationale, including the nature of urg ent problems where 
applicable:  Protection of human health or safety  G/TBT/N/BRA/1081  
 
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  8. Relevant documents:  1) Brazilian Official Gazette 180 on 18 September 2020, 
section  1, page 110; 2) Term of Opening of Proceedings (TAP) No. 106 of 21/09/2020; 
3) Motivation about the proposal and justification of exemptions from RIA and Public 
Consultation  
https://www.in.gov.br/web/dou/ -/resoluc ao-de-diretoria -colegiada -rdc-n-423-de-16-de-
setembro -de-2020-278150627  
http://antigo.anvisa.gov.br/legislacao#/visualizar -etapa/433538  
http://antigo.anvisa.gov.br/legislacao#/visualizar/432115  
9. Proposed date of adoption:  In the date of its publication  
Proposed date of entry into force:  In the date of its publication  
10. Final date for comments:  Not applied  
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/legislacao#/visualizar/432115