G/TBT/N/BRA/855  
 
3 January 2019  
(19-0008) 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:  
National Institute of Metrology, Quality and Technology (INMETRO)  
Telephone: +(55) 21 2563.2840  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.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_aplicac ao=28757  
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:   
Brazilian Health Regula tory Agency (Anvisa)  
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  584, 21 December 2018, published by Brazilian Official Gazette (5 page(s), in 
Portuguese)   
6. Description of content: This draft resolution proposes the medical devices classification 
as single use or reusable, among other measures.  
This resolution has the objective of establishing the medical device classification as single 
use or reusable for regularization with Anvisa, as well as information to be considered on  
the instructions for use and the label of such devices.  
This resolution does not apply to in vitro diagnostic products.  
This resolution applies to manufacturers and importers of medical devices, registration 
holders, as well as health services. It also ap plies to the processing companies of health 
products regarding planning and execution of processing activities of medical devices.  
The registry holder is responsible for evaluating and establishing the classification of the 
device in one of the options presented in this document, from the project of the medical 
device, based on technical -scientific evidence, risk assessment and valida tion of project 
and applicable process.  G/TBT/N/BR A/855  
 
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  Manufacturers shall define, establish and document the technical -scientific rationale that 
corroborates the proposed classification for the medical device.  
The Resolution of Collegiate Board of Directors  - RDC No. 1 56 of 2006 and Specific 
Resolution  - RE No. 2605, of 2006 is hereby revoked.  
This Resolution shall enter into force 60 days from the date of its publication.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human Health  
8. Relevant documents:  Not Applicable   
9. Proposed date of adoption:  60 days from the date of its publication.  
Proposed date of entry into force:  60 days from the date of its publication.  
10. Final date for comments: 60 days from notification  
11. Texts available from: National enquiry point [  ] 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 Espec ial 57  
Brasília - DF / Brazil  
CEP: 71.205 -050 
Phone.: +(55) 61 3462.5402  
Website: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/3898778/CONSULTA+PUBLICA+N+453+
GGMED.pdf/bb63a56f -9d2f-4776-9eee-93c239449e1b  
http://portal.anvisa.gov.br/documents/10181/3898778/RET_CP_453_2017.pdf/5ee841
a3-254c-4380-b8e4-971400046b25