G/TBT/N/BRA/828  
 
29 June 2018  
(18-4122) 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  
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): Linear or 
two-dimensional bar code  
5. Title, number of pages and language(s) of the notified document: Resolution  – RDC 
nº 232 of 20 June 2018 (3 page(s), in Portuguese)   
6. Description of content:  
This Resolution establishes the obligation to include a linear or two -dimensional bar code 
on stent traceability labels for coronary arteries, pharmacological stents for  coronary 
arteries, and implants for hip and knee arthroplasty.  
Article 1. It is established the mandatory inclusion of linear barcode or two -dimensional, in 
accordance with IMDRF / UDI document WG / N7 Final: 2013 - UDI Guidance: Unique 
Device Identification (UDI) of Medical Devices on traceability labels for single identification 
of stents for coronary arteries, coronary artery stents, and implants for hip and knee 
arthroplasty, for traceability and control purposes to be performed within the s cope of the 
National Registry of Implants - RNI. 
Article 3. The bar code shall contain the following data:  
I - device identifier;  
II - date of validity; and  
III - batch or serial number.  
Article 4. The provision of the bar code should not prejudice the vis ualization of the other 
information provided in the current legislation for traceability labels.  
Article 6. A bar code other than the one specified in this Resolution may not be included in 
the traceability label.  G/TBT/ N/BRA/828  
 
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  Article 7. The availability of traceabilit y labels containing the bar code on medical device 
packaging shall be made by the manufacturer or importer.  
Article 8. The inclusion of the bar code in the labels of traceability will not be considered a 
change for the purposes of registration, dispensing authorization or notification to ANVISA.  
Single paragraph. Medical devices manufactured prior to the effective date of this 
Resolution are exempt from the requirements established in this regulation.  
Article 10. This Resolution comes into force two (2) yea rs after its publication  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  (1) Brazilian Official Journal 120, 25 June 2018 (Diário Oficial da 
União de 25 de Junho  de 2018); (2) RDC n° 59 of 25 August 2008; (3) Brazilian Official 
Journal (Diário Oficial da União); (4) Not stated   
9. Proposed date of adoption:  On the date of its publication  
Proposed date of entry into force:  2 (two) years after its publication  
10. Final date for comments: Not applicable  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Coordinator of International Liaison and Regulatory Convergence  
International Affairs Office  
Brazilian Health Regulatory Agency - ANVISA  
Tel: +55 (61) 3462 -5402/5404/5406  
E-mail: rel@anvisa.gov.br  
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/4580265/RDC_232_2018_COMP.pdf/e8380b
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