G/TBT/N/BRA/590  
 
3 June 2014  
(14-3227)  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):  In vitro 
diagnosis products 
5. Title, number of pages and language(s) of the notified document:  Draft Resolution 
No. 23, 13 May 2014, that disposes about in vitro diagnosis products (19 pages, in 
Portuguese).     
6. Description of content:  This draft Resolution establishes the necessary requirements 
to register, cancel, alter and revalidate in vitro diagnosis products. 
This draft resolution applies to products which are manufactured or imported to Brazil 
and which are classified according to some risk criteria and its goals. 
According to this draft technical regulation, the registration, alteration, revalidation and 
cancellation of the registration of these pr oducts are made under de presentation of 
some general and documental requirements. 
For purposes of regularization of the produc ts at Anvisa, IVD products are classified 
under the following classes: 
I - Class I: low-risk products to individuals and low risk to public health; II - Class II: products of medium risk to individuals and / or low risk to public health; 
III - Class III: high-risk products to individuals and / or medium risk to public health; 
and 
IV - Class IV: high-risk products to individuals and high risk to public health. According to the risk classification of the IV D product, it will have different requirements 
to be regularized at Anvisa, as expressed in  articles 18, 19 and 20 of the draft technical 
regulation. G/TBT/N/BRA/590 
 
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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), 20 May 2014; 
Section 1, p. 36, Draft Resolution (Consulta Pública) number 23, 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:    Upon publication in the Official Journal after 
received comments have been taken into 
account Upon publication in the Official Journal after received comments have been taken into 
account 
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   
Web: 
http://portal.anvisa.gov .br/wps/wcm/connect/da2b6180441149408452be94043333b2/con
sulta+p%C3%BAblica+n%C2%B0+23+GGTPS.pdf?MOD=AJPERES