G/TBT/N/BRA/842  
 
17 September 2018  
(18-5706) 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: Brazilian Health Regulatory 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, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmet ro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas    
The comments to this Draft Regulation shall be sent to  
http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=33294  
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  546, 3 September 2018 (12 page(s), in Portuguese)    
6. Description of content: This Draft Resolution 546/2018 lays down technical 
requirements for the manufacturing, marketing, import, export and exposure to use of 
custom -made and patient specific medical devices and medical devices exempt from 
registration.  
This Draft Resolution does not apply to active medical device, in vitro diagnostic medical 
devices, medical devi ces under clinical investigation and services provided by 
dental  prosthesis laboratories.  
The requirements established in this Resolution address, among others: good 
manufacturing practices, labelling, traceability labels, technovigilance, product dossier,  
safety and efficacy requirements.  
The adaptable medical device is regulated by Anvisa and must comply to the requirements 
established in the Collegiate Board Resolution - RDC nº 185, from 22 October 2001, 
Collegiate Board Resolution - RDC nº 40, from 26 A ugust 2015 and other current specific 
regulations.  
Custom -made and patient specific medical devices national manufacturing and import 
companies must keep documents to ensure traceability to the patient.  
Anvisa will not provide previous authorization for product manufacturing  for custom -made  
and patient specific medical devices.  G/TBT/N/BRA/842  
 
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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:   
Collegiate Board Resolution - RDC nº 56, from 06 April 2001; Collegiate Board Resolution - 
RDC nº 185, from 22 October 2001; Collegiate Board Resolution - RDC nº 67, from 
21 December 2009; Collegiate Board Resolution - RDC nº 16, from 28 March 2013; 
Collegiate Board Resolution - RDC nº 40 , from 26 August 2015.   
9. Proposed date of adoption: On the date of its publication  
Proposed date of entry into force: 90 days after the date of its publication  
10. Final date for comments: 12 November 2018  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
Agency Responsible  
Brazilian Health Regulatory Agency (Anvisa)  
SIA, Trecho 5, Área Especial 57  
Brasília - DF/Brazil  
CEP: 71.205 -050 
Phone.: +(55)  61 3462.5402  
Website: http://portal.anvisa.gov.br/english   
http://portal.anvisa.gov.br/documents/10181/3254343/CONSULTA+P%C3%9ABLICA+N%
C2%BA+546+GGTPS.pdf/9cb02cdb -903d-41a2-a168-8f7f005fb8ba