  
  
G/TBT/N/BRA/1121  
18 January 2021  
(21-0547) 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):  
HS Code(s): 30041090, 30049099, 30042019 (artificial tears and lubricating eye drops)  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 458, 21 December 2020 . (4 page(s), in Portuguese)  
6. Description of content:  This resolution establishes the technical requirements for the 
market registration process of artificial tears and lubricating eye drops and changes the 
Resolution – RDC number 185, 22 October 2001, which regulates the market registration 
process of medical devices.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health or safety  
8. Relevant documents:  1) Brazilian Official Gazette 245 on 23 December 2020, section  1, 
page 127; 2) RDC number 185, 22 October 2001  
https://www.in.gov.br/web/dou/ -/resolucao -de-diretoria -colegiada -rdc-n-458-de-21-de-
dezembro -de-2020-295779360  
http://antigo.anvisa.gov.br/documents/10181/2718376/%282%29RDC_185 _2001_CO
MP.pdf/aa2210c7 -a354-469e-b60c-e5824a53c828  
9. Proposed date of adoption:  2 January 2021  
Proposed date of entry into force:  2 January 2021  
10. Final date for comments:  Not applied  G/TBT/N/BRA/1121  
 
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  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/10181/6111703/RDC_458_2020_.pdf/e66310da
-4d68-4b32-be31-7b117849d74d  
 