. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/454 
13 January 2012  
 (12-0180) 
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, Standard ization and Industrial Quality - INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2502.6542 Email:  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):  Medical devices.  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 62, 
15 December 2011 - Sets criteria fo r optimization of internationa l inspections for verification 
of compliance with Good Manufacturing Prac tices for medical devi ces  and "in vitro" 
diagnostic medical devices (3  pages, Portuguese)     
6. Description of content:  This draft resolution sets criteria for optimization of international 
inspection for verification of compliance with  Good Manufacturing Pr actices for medical 
devices and "in vitro" di agnostic medical devices.  
This Resolution establishes the methodology to be used in scheduling international 
inspections for verification of compliance wi th Good Manufacturing Practices for medical 
devices and "in vitro" diagnost ic medical devices, including criteria for prioritizing 
inspections for verification of GMP.  
This Resolution applies to appl ications filed at Anvisa of GMP Certificates of medical 
devices and “in vitro” diag nostic medical devices for plants located abroad.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/454 
Page 2  
 
  8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 19 December 
2011; Section 1. Draft Resolution (Consulta Públ ica) number 62, 15 December 2011, issued 
by the Brazilian Health Regulat ory Agency - Anvisa; When a dopted, 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:   2 February 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:  http://www.anvisa.gov.br/  
"http://portal.anvisa.gov.br/wps/wcm/ connect/16a2bd00497a794183dcf74ed75891ae/CP+N%
C2%B0+62+GGIMP.pdf?MOD=AJPERES "