. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/433 
30 May 2011  
 (11-2711) 
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 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, Standard ization and Industrial Quality - INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 
E-mail:  barreirastecnicas@inmetro.gov.br
 
Website:  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):  Establishment licence 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 25, 
April 8th  2011 - Criteria for granting establishment licence for companies that commercialize medical devices (3 pages, in Portuguese). 
6. Description of content:  This draft technical regulation esta blishes criteria for granting an 
establishment licence (AFE - "Autorização de F uncionamento de Empresa") to establishments 
that sell medical devices in Brazil.   
All establishments that  commercialize me dical devices in Brazil, in cluding in vitro diagnostic 
products, shall have an establishment licence (AFE) granted by the local brazilian health 
surveillance authority.  
It will be granted a period of 180 (one hundred and eighty) days from the date of entry into 
force of this Resolution for establishments to  promote the necessary adjustments to comply 
with this resolution. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/433 
Page 2  
 
  8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), April 13th, 2011; 
Section 1 page 27. Draft Resolution (Consulta P ública) number 25, April 8th, 2011, issued by 
Brazilian Health Regulatory Agency - Anvisa; When adopted , it will be published in the 
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:  13 June 2011 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:  
Brazilian Health Regulatory Agency – ANVISA 
SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil CEP:  71.205-050 Tel.:  55 61 3462-5402 
E-mail:  rel@anvisa.gov.br
  
Website:  http://www.anvisa.gov.br  
Text can be downloaded at: 
"http://portal.anvisa.gov.br/wps/wcm/co nnect/9c0fdf804637d1a885cebf0ce2062da6/CP+N
%C2%BA+14+GGMED.pdf?MOD=AJPERES "