G/TBT/N/BRA/1112  
4 January 2021  
(21-0002) 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):  - Gloves, 
mittens and mitts : (HS 40151); Safety headgear, whether or not lined or trimmed (HS 
650610); Spectacles, goggles and the like, corrective, protective or other (excl. 
spectacles for testing eyesight, sunglasses, contact lenses, spectacle lenses and frames 
and mountings for spectacles) (HS 900490); Breathing appliances and gas masks (excl. 
protective masks having neither mechanical parts nor replaceable filters, and artificial 
respiration or o ther therapeutic respiration apparatus) (HS 9020)  
5. Title, number of pages and language(s) of the notified document:  Resolution 
number 444, 10 December 2020. (11 page(s), in Portuguese)  
6. Description of content:  This resolution establishes temporary an d extraordinary 
requirements for the fabrication, importation and commercialization of personal protective 
equipment identified as priority for use at health services, due to the Public Health 
Emergency of International Concern related to the SARS -CoV-2 pandemic.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  According to market monitoring and surveillance data, it was found the 
difficulty in supervising the compliance with RDC No. 356 of 20 and acting consistently in  
ensuring the quality, safety and efficacy of products in circulation in the national market. 
In addition, several companies have expressed concern about the possible expiry of RDC 
No. 356 of 20, amended by 379 of 20, to the effect of the period necessary for depletion 
of stock of products manufactured or imported under the exceptionality regime. Thus, in 
order to increase regulatory predictability, it is suggested the definition of a deadline for 
exhaustion of the remaining stock of 120 days for products m anufactured or imported, 
after the end of the term of the Resolution.; Protection of human health or safety  G/TBT/N/BRA/1112  
 
- 2 - 
 
  8. Relevant documents:   
1) Brazilian Official Gazette 241 on 17 December 2020, section 1, page 171  
 https://www.in.gov.br/web/dou/ -/resolucao -rdc-n-448-de-15-de-dezembro -de-2020-
294648890  
9. Proposed date of adoption:  On the day of its publication  
Proposed date of entry into force:  On the day of its publication  
10. Final date for comments:  Not applicable  
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/10181/6156982/RDC_448_2020_.pdf/7daf7838
-fb07-4a1f-8b7d-5425df7c2ccd