G/TBT/N/BRA/1167  
27 April 2021  
(21-3520) 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. 1042, 8 April 2021. (9 page(s), in Portuguese) . Draft: 
http://antigo.anvisa.gov.br/documents/10181/6254098/Minuta+1042.pdf/67d15531 -
b822-46ec-97a3-a3c936e69c12   
Comment f orm: https://pesquisa.anvisa.gov.br/index.php/934179?lang=pt -BR  
6. Description of content:  Public Consultation proposal to establish technical requirements 
for the classification of orthopaedic implantable materials for the purpose of market 
authorization.   
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of human health. As rapid technological innovations in the health 
sector occur, there is a need for continuous monitoring of access to new medical products 
and the periodic review of regulations to converge with international regulations. In th e 
case of implantable materials in orthopaedics, there is a growing increase in new products, 
which are presented in different systems, families and sets. These sets are not provided 
for in the framework possibilities of the resolution now in force applica ble to 
manufacturers and importers of orthopaedic implantable materials. The objective of the 
regulation is to review the technical regulations of Anvisa, Resolution RDC No. 59/2008, 
and the Normative IN No. 1/2009 in order to discipline the grouping in th e family or 
system of implantable materials in orthopedics for registration purposes and other 
arrangements. Thus, establishing the technical requirements and criteria for companies 
that make and import which can be applied when framing implantable materia ls in G/TBT/N/BRA/1167  
 
- 2 - 
 
  orthopaedicsincorporating innovations and minimizing the intrinsic risks involved.; 
Protection of human health or safety  
8. Relevant documents:  01) Brazilian Official Gazette 65 -A on 08 April 2021, section 1, 
page 3; 02) Regulatory Impact Analysis ( RIA) Report; 03) Justification for the draft 
resolution  
https://www.in.gov.br/web/dou/ -/consulta -publica -n-1.042 -de-8-de-abril-de-2021-
312902399  
http://antigo.anvisa.gov.br/documents/10181/6254098/REMAI.pdf/a20cdef1 -db89-
40cf-a000-5d0adc1e51f5   
http://antigo.anvisa.gov.br/documents/10181/6254098/Parecer+com+as+Justificativas
+regulat%C3%B3rias.pdf/e3efb9ea -5866-49e1-9542-be8b41636753  
9. Proposed date of adoption:  Not applicable  
Proposed date of entry into force:  Not applicable  
10. Final date for comments:  15 June 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  
http://antigo.anvisa.gov.br/documents/10181/6254098/Minuta+1042.pdf/67d15531 -
b822-46ec-97a3-a3c936e69c12