. /. WORLD TRADE  
ORGANIZATION   
G/TBT/N/BRA/153 
18 May 2004 
 (04-2178) 
Committee on Technical Barriers to Trade Original:  English 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   BRAZIL 
If applicable, name of local government involved (Articles 3.2 and 7.2):         
2. Agency responsible:   Brazilian Sanitary Surveillance Agency – ANVISA 
 Telephone: +(55) 61 448 1078 Fax:  +(55)61 448 1089 
E-mail:  rel@anvisa.gov.br 
Web site: www.anvisa.gov.br  
Name and address (including telephone and fax numbers, e-mail and web-site 
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, Standardizati on and Industrial Quality-INMETRO 
 Telephone: +(55) 21 2563.2821 Telefax: +(55) 21 2502.6542 
Email:  barreirastecnicas@inmetro.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 app licable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Medical devices; 
instruments and appliances used in medical, surgical, dental or veterinary sciences, 
including scintigraphic apparatus, other el ectro-medical apparatus and sight-testing 
instruments (HS 9018). 
5. Title, number of pages and language(s) of the notified document:   Draft Resolution 
number 17, 22 March 2004 ( Consulta Pública nº 17, de 19 de março de 2004)  issued by the 
Brazilian Sanitary Surveillance Agency on the re -use of certain medical devices (6 pages, in 
Portuguese). 
6. Description of content:   Draft Technical Regulation listin g the medical devices that cannot 
be used more than once and es tablishing the procedures relative to medical devices that can be 
reused.   
It also reinforces the prohibition of impor t and trade of used medical devices.  
Products that cannot be used more than on ce, must show in its label the warning “ PROIBIDO 
REPROCESSAR ”  (Reprocessing forbidden)  
 
Manufacturers and im porters of medical devices which are listed on article 3 of the proposed 
Resolution have 180 days to comply with thes e requirements and must  request Anvisa to 
proceed with the necessary labelling changes, without further costs.  G/TBT/N/BRA/153 
Page 2  
 
When entering into force, this resolution wi ll revoke Ministerial Acts  numbers 3 and 4, 7 
February 1986 ( Portarias no. 3 e 4 de 7 de fevereiro de 1986 ) and the Ministerial Act 4, 
from 8 July 1988 ( Portaria no. 4, de 8 de julho de 1988 ). 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Labelling and consumer’s safety 
8. Relevant documents:   Resolution RDC number 56, 6 April 2001 ( Resolução - RDC nº 56, 
de 6 de abril de 2001 ). http://www.anvisa.gov.br/legis/resol/56_01rdc.htm 
9. Proposed date of adoption:   
Proposed date of entry into force:   Not defined 
10. Final date for comments:   22 June 2004 
11. Texts available from:  National enquiry point [  X ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:  
http://www4.anvisa.gov.br/base/visadoc/CP/CP[6781-1-0].PDF