  
  
G/TBT/N/BRA/1017  
11 June 2020  
(20-4140) 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:   
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2145.3817  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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:   
Brazilian Health Regulatory Agency (ANVISA)  
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): Medical devices (2936, 2937, 3001, 3002, 3003, 3004, 3006)  
5. Title, number of pages and language(s) of the notified document:  Resolution – 
RDC number 378, 28 April 2020 (3 page(s), in Portuguese)  
6. Description o f content:  This resolution extraordinarily and temporarily establishes 
technical requirements for the import, marketing, and donation of lung ventilators, vital 
signs monitor, infusion pump sets, oximetry machine, and used capnographs, 
indispensable for in tensive care units, due to the international public health emergency 
related to the Covid -19.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health  
8. Relevant documents:  (1) Brazilian Official Gazette (Diário Oficial da União) 82 -B, of 
30 April 2020, section 1, page 90; (2) Not stated; (3) Brazilian Official Gazette; (4) Not 
stated.  
9. Proposed date of adoption:  In the date of its publication  
Proposed date of entry into force:  In the d ate of its publication  
10. Final date for comments:  Not applied  G/TBT/N/BRA/1017  
 
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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://portal.anvisa.gov.br/documents/10181/5868576/RDC_378_2020_.pdf/76614d07 -
781b-4108-91ba-069ced2f1569  
 