G/TBT/N/BRA/1166  
27 April 2021  
(21-3526) 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): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)   
5. Title, number of pages and language(s) of the notified document:   
Public Consultation No. 1043, 8 April 2021. (6 page(s), in  Portuguese)  Draft: 
http://antigo.anvisa.gov.br/documents/10181/4859043/Minuta+de+CP.pdf/39d90f00 -
e9e7-4619-adbe-75ff38ec0cd6   
Comment  form: https://pesquisa.anvisa.gov.br/index.php/447285?lang=pt -BR  
6. Description of content:  Public Consultation Proposal to establish technical requirements 
for the import, comme rcialization, and donation of used reprocessed medical devices.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health. Resolution - RDC No. 25/2001, which provides 
for the import, marketing and donation of used and refurbished health products, was 
published approximately 20 (twenty) years ago, from the perspective of the current 
market at the t ime, prohibits the marketing and donation of equipment used in Brazil, 
preventing the increase of access to health facilities with less financial resources health 
equipment and instruments for in vitro diagnostics used. Thus, there is a need to update 
the regulation with the reality of the health equipment market and instruments for in vitro 
diagnostics, to include new marketing concepts, such as: leasing, overhearing, leasing, 
trade in payment. The concept of reconditioning of outdated equipment and out of  the 
context used internationally. The objective of this regulation is to enable safely the 
commercialization and donation in Brazil of health use equipment and instruments for in 
vitro diagnostics used, which are in good conditions of use, enabling and ex panding the 
access of health facilities with less financial resources to such equipment and instruments. 
Another objective is to meet minimum safety requirements that ensure the proper use of 
equipment and instruments, including maintenance and traceabilit y controls, linked to the G/TBT/N/BRA/1166  
 
- 2 - 
 
  responsibility of the commercialization or donation, even after the expiration of the 
validity of the registration of health equipment in Anvis a; Protection of human health or 
safety  
8. Relevant documents:  01) Brazilian Official Gazette 65 -A on 08 April 2021, section 1, 
page 4;02) Regulatory Impact Analysis (RIA) Report  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-1.043 -de-8-de-abril-de-2021-
312834002  
http://antigo.anvisa.gov.br/documents/10181/4859043/Relatorio_AIR.pdf/9695651f -
2e10-4649-b509-660b33cbd742  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments:  14 May 2021  
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/10181/4859043/Minuta+de+CP.pdf/39d90f00 -
e9e7-4619-adbe-75ff38ec0cd6