G/TBT/N/BRA/754  
 
25 October 2017  
(17-5798) 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 2563.2765  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=32938  
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 90  
5. Title, number of pages and language(s) of the notified document: Draft resolution 
number 408, 3 September 2017 (4 page(s), in Portuguese)    
6. Description of content: This Draft Resolution provides for the mandatory inclusion of 
UDI / IMDRF standard barcode on traceability tags for cardiological stents, hip and knee 
implants.  
The mandatory inclusion of a UDI / IMDRF standard barcode as the technology for 
capturing, storing and transmitting data on the traceability tags of cardiac stents, hip and 
knee implants is established for the proper tracking and control to be performed within the 
scope  of the National Registry of Implants - RNI. 
The bar code referred to in the caput of this article shall comply with the technical 
standards established by the International Technical Standards ISO and IMDRF, listed in 
the Annex to this Resolution, in orde r to ensure the reading by electronic data capture 
mechanisms throughout the chain of products, minimally during the life of the product.  
The arrangement of the bar code should not prejudice the visualization of the other 
information in the current legisla tion for traceability labels.  
The inclusion of the traceability labels containing the bar code in the consumer packaging 
shall be carried out by the holder of the registration or international manufacturer.  
7. Objective and rationale, including the nature  of urgent problems where 
applicable: Protection of Human Health  G/TBT/N/BRA/754  
 
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  8. Relevant documents:  (1) Brazilian Official Journal (Diário Oficial da União) Nº 191, 
4 October 2017, section 1, pages 41; (2) Law 9.782, 26 January 1999; Resolution RDC 61, 
3 February 2016 (3) Brazilian Official Journal; (4) Not applicable   
9. Proposed date of adoption: To be determined after the end of the consultation period.  
Proposed date of entry into force: 180 (one hundred and eighty) days after its 
publication.  
10. Final date f or comments: 11 December 2017  
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
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/10181/3427303/CONSULTA+PUBLICA+N+408+GG
TPS.pdf/408d7f61 -55f6-4a8d-803b-796e2058d684