. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/233 
15 February 2007 
 (07-0658) 
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 
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, Standa rdization and Industrial Quality-Inmetro 
 
Telephone: +(55) 21 2563.2821 
Telefax: +(55) 21 2502.6542 
Email:  barreirastecnicas@inmetro.gov.br Website: 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):   Electrical devices 
5. Title, number of pages and language(s) of the notified document:   Draft Resolution nº 
92, 18 December 2006 – Technical regulation on mandatory certification of electrical devices under sanitary surveillance sco pe (3 pages, in Portuguese). 
6. Description of content:   This draft technica l regulation establishes mandatory certification 
for all electric devices regulated under sanitary surveillance scope and also lists its necessary requirements and procedures.  These electrical  devices are the ones used for medical, 
odontological, physiotherapeutic or beautif ication/aesthetics purpose when monitoring, 
diagnosing or treating human beings.  
It revokes ANVISA Resolution – RDC nº 444, 31August 1999. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Guarantee the Quality, Security and Efficacy of Products and Protection of Consumer 
Health. 
8. Relevant documents:   Brazilian Official Journal (Diári o Oficial da União), 20 December 
2006; Section 1, page 92. Draft Resolution (Consulta Pública) number 92, 18 December 
2006, issued by Brazilian Sanitary Surveilla nce Agency – Anvisa; to be published at 
Brazilian Official Journal. Available in Portuguese. G/TBT/N/BRA/233 
Page 2  
 
  9. Proposed date of adoption:   
Proposed date of entry into force:    March 2007 
Immediately after the Resolution had been publicised (for new registration requests). 
10. Final date for comments:   20 February 2007 
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:   
National enquiry point  
National Institute of Metrology, Standa rdization and Industrial Quality-Inmetro 
 
Telephone: +(55) 21 2563.2821 
Telefax: +(55) 21 2502.6542 
Email:  barreirastecnicas@inmetro.gov.br 
Website: www.inmetro.gov.br/barreirastecnicas 
 
Agency responsible: 
 Brazilian Sanitary Surveillance Agency – ANVISA 
SEPN 515 - Bloco "B", Edificio Omega CEP 70770-502 Brasilia – DF/Brasil 
Telephone: +(55) 61 3448 1078 
E-mail:  rel@anvisa.gov.br  
Website: www.anvisa.gov.br  The full text of the pr oposed technical regulation can be directly accessed th rough the link: 
http://www4.anvisa.gov.br/base/visadoc/CP/CP[17071-1-0].PDF