G/TBT/N/BRA/601  
 
13 August 2014  
(14-4691)  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 2563.2821 
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 applic able, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable): Clinical trials with 
medical devices. 
5. Title, number of pages and language(s) of the notified document: Draft Resolution 
no. 64, 1 August 2014 that disposes about the clinical trials with medical devices 
accomplished in Brazil. (24 pages, in Portuguese).     
6. Description of content: This draft technical resolution establishes the procedures and 
requirements to the accomplishment of clinical trials with medical devices in Brazil, 
including the procedures and requirements to the approval by the Brazilian Health 
Surveillance Agency – ANVISA of the Dossier of a Medical Device Clinical Investigation. The 
accomplishment of clinical trials involving medical devices in Brazil requires prior consent 
of ANVISA.  
This draft resolution is applicable to clinical investigation with medical devices of risk 
classes III and IV, which will have all its clinical development, or part of it, in Brazil, in 
order to generate evidences of its efficacy, performance or safety, necessary to the 
registration by ANVISA. 
The clinical investigations with medical devices that have been initiated before the entry 
into force of this technical resolution, and that are not yet regularized at ANVISA, will have 
one year to adjust themselves to this regulation. The non-compliance with the terms of this regulation will be considered sanitary infraction, according to Federal Law 6.437/77. 
This draft resolution revokes the following technical Resolutions: RDC n. 39/2008; RDC n. 
36/2012; and items 1 and 1.1 of Section I, item s 2, 2.1 and 2.1.1 of Section II of Chapter 
XXVI of RDC 81/2008, for clinical trials with medical devices. G/TBT/N/BRA/601 
 
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  7. Objective and rationale, including the nature of urgent problems where applicable: 
Protection of Human health or Safety 
8. Relevant documents:  Brazilian Official Journal (Diário Oficial da União), August 04th 
   2014; Section 1, p. 73, Draft Resolution (Consulta Pública) number 64, August 01th 
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: To be determined after the end of the consultation period.  
Proposed date of entry into force: To be determined after the end of the consultation 
period.   
10. Final date for comments: 11 September 2014 
11. Texts available from: National enquiry point [  ] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
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   
Website: http://www.anvisa.gov.br  
 
http://portal.anvisa.gov.br/wps/wcm/conne ct/e467158044fb026bbc7ebcc5b6e3ae4b/Consul
ta+P%C3%BAblica+n%C2%B0+64+SUALI.pdf?MOD=AJPERES