. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/440 
20 July 2011  
 (11-3622) 
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, Standa rdization and Industrial Quality-INMETRO 
Telephone:  +(55) 21 2563.2821 Telefax:  +(55) 21 2563.5637 Email:  mailto: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 34, 
June 28th  2011 – Used, refurbished,  rented and lent medi cal devices (6 pages, Portuguese).     
6. Description of content:  This draft resolution regulates used , refurbished, rented and lent 
medical devices that must be registered at Anvisa accordi ng to Resolutions  RDC 185/2001 
and RDC 24/2009.   
Medical devices that are covered by this Resolu tion are, including their parts and accessories: 
- devices used for medical, dental, labora torial and physical therapeutic purposes, 
directly or indirectly used for diagnosi s, treatment, rehabilitation and humans 
monitoring. 
- devices used for beauty and esthetic purposes.  
Import, marketing, commercialization, exchange , donation and sale of used medical devices 
are forbidden in Brazilian territory, unless the me dical devices have been through a process of 
reconditioning, according to the criteria es tablished in this T echnical Regulation. 
This resolution will revoke resolution RDC nº 25, 15 February 2001.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health  G/TBT/N/BRA/440 
Page 2  
 
  8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), July 1st 2011; 
Section 1 page 64. Draft Resolution (Consulta P ública) number 34, June 28th 2011, issued by 
Brazilian Health Regulat ory 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:  1 September 2011 
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:    
Agency responsible 
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:  mailto:rel@anvisa.gov.br   
Website:  http://www.anvisa.gov.br  
http://portal.anvisa.gov.br/wps/wcm /connect/6bd86b00477801d9bc23be 5c9a854df2/CP_34_
2011_GGTPS.pdf?MOD=AJPERES