G/TBT/N/BRA/591  
 
3 June 2014  
(14-3228)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: English  
 
NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6 
 
1. Notifying Member:  BRAZIL  
If applicable, name of local government involved (Article 3.2 and 7.2):     
2. Agency responsible:  ANVISA - Brazilian Health Surveillance Agency 
Name and address (including telephon e 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, Quality and Technology - INMETRO 
Telephone: +55 (21) 2563.2840 
Telefax:  +55 (21) 2563.5637 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 24, 13 May 2014 that defines the requirements for registration at Anvisa of low and 
medium risk medical devices for sanitary control (10 pages, in Portuguese).     
6. Description of content:  This draft Resolution establishes the requirements for 
registration at Anvisa of low and medium risk medical devices for sanitary control.  
This draft Resolution applies to medical devices classified as Class Risk I and II.  According to this draft technical regulation, to  request the registration of medical devices 
classified as Class Risk I and II and its alteration, the manufacturer or the importer must 
present a list of specific documents.   
The technical dossier, containing all documents and information, must be regularly 
updated by the national manufacturer or the importer to Anvisa. 
According to this draft technical regulation, the medical devices Class Risk I and II 
registered at Anvisa are exempt from reva lidation. They must observe GMP, technical 
standards and specific standards, accord ing the Brazilian System of Conformity 
Assessment – SBAC, when applicable, as expre ssed in Article 10 of the draft technical 
regulation. 
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human health or Safety G/TBT/N/BRA/591 
 
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  8. Relevant documents:   Brazilian Official Journal (Diário Oficial da União), 20 May 2014; 
Section 1, p. 36, Draft Resolution (Consulta Pública) number 24, 13 May 2014, issued by Brazilian Health Surveillance Agency – Anvisa. When adopted, it will be published at 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  
30 days after the date of adoption. 
10. Final date for comments:  25 July 2014 
11. Text available from:  National enquiry point [  ], or address, telephone and fax 
numbers, e-mail and web-site addresse s, if available of the other body:    
Agency responsible 
Brazilian Health Surveillance 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   
http://portal.anvisa.gov.b r/wps/wcm/connect/8df5d3804411512f846dbe94043333b2/Con
sulta+P%C3%BAblica+n%C2%B0+24+GGTPS.pdf?MOD=AJPERES