. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/452 
13 January 2012  
 (12-0164) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  BRAZIL  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Health Surveillance 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 2563.2821 Telefax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br  
Web-site:  http://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):  In vitro diagnostic medical 
devices.  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 57, 
December 2nd 2011 – Modifies Re solution RDC nº 206 November 17th 2006 that contains a 
technical regulation that establishes require ments for registration, future amendments, 
revalidation and cancellation of registration of in vitro diagnost ic medical devices. Normative 
Instruction that establishes rules for the provision of instructions for use in non-print format of 
medical devices (3 pages, Portuguese).     
6. Description of content:  This draft resolution modifies resolution RDC nº 206 November 
17th 2006 that contains a technical regulation that  establishes requiremen ts for registration, 
future amendments, revalidati on and cancellation of registra tion of “in vitro” diagnostic 
medical devices.  
The RDC nº 206 17 November 2006 has been modi fied in its Annex on items 1.12-A, 3 and 
3.2. 
It also establishes rules for the provision of inst ructions for use in non- print format of medical 
devices.  
This Normative Instruction establishes require ments for providing instructions for use in non-
print format of medical devices subject to regist ration, used in health services facilities and by 
qualified prof essionals. G/TBT/N/BRA/452 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  
8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 7 December 
2011; Section 1 page 42. Draft Resolution (Con sulta Pública) number 57, 2 December 2011, 
issued by Brazilian Health Re gulatory Agency - Anvisa; When adopted, it will be published 
at Brazilian Official Journal. Available in Portuguese.   
9. Proposed date of adoption:   
Proposed date of entry into force:    To be determined after the end of the 
consultation period.  On the date of adoption. 
10. Final date for comments:  9 January 2012. 
11. Text available from:  National enquiry point [X], or address, telephone and fax 
numbers, e-mail and web-site addres ses, if available of the other body:    
National enquiry point 
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 
E-mail:  rel@anvisa.gov.br   
Website:  www.anvisa.gov.br 
http://portal.anvisa.gov.br /wps/wcm/connect/6d1fd80 04956805baf32ff4ed75891ae/CP+N%C
2%BA+57+GGTPS.pdf?MOD=AJPERES