G/TBT/N/BRA/816  
 
31 May 2018  
(18-3267) 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 2563.2765  
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): Self-test 
instruments for glucose and its consumables.  
5. Title, number of pages and language(s) of the notified document: Normative 
Instruction number 24, 17 May 2018. (1 page(s), in Portuguese)   
6. Description of content: This Normative Instruction establishes the parameters of the 
Technical Norm ISO 15197: 2013 - In vitro diagnostic test systems - Requirements for 
blood glucose monitoring systems for self -testing in managing diabetes mellitus, as 
requirements to be adopted and observed by the manufacturers of self -test instruments 
for glucose  and its consumables for registration purposes, changes and revalidation of 
registration with Anvisa.  
The items of the Technical Dossier provided in art. 29 of the Resolution of the Collegiate 
Board of Directors - RDC 36 of 26 August 2015, applicable to th e instruments for glucose 
self-test and its consumables must be met through the inclusion of reports prepared 
according to the analytical performance evaluation chapte r of the Standard Technique 
ISO 15197: 2013.  
The reports prepared, cited in article 2, sh all be presented within a maximum period of 
180 (one hundred and eighty) days after the publication of this Normative Instruction.  
Product registrations that do not demonstrate complian ce with the requirements of 
ISO 15197: 2013 will be cancelled.  
In the e vent that the Technical Standard indicated in this Normative Instruction be 
replaced by an updated version, the updated version will be required according to the G/TBT/N/BRA/816  
 
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  transition period recommended by the text of the updated Technical Standard.  
Failure to comply  with the Technical Note requirements within the established deadline will 
result in the cancellation of the registration of the product in question.  
7. Objective and rationale, including the nature of urgent problems where 
applicable: Protection of Human  Health  
8. Relevant documents:  Resolution RDC 36, 26 August 2015 notified under the document 
G/TBT/N/BRA/590/Add.1.   
9. Proposed date of adoption:  On the date of its publication  
Proposed date of entry into force:  On the date of its publication  
10. Final date for comments: Not applicable  
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: www.anvisa.gov.br  
http://portal.anvisa.gov.br/documents/10181/2718376/IN_24_2018_.pdf/4381cad6 -3c9f-
4a1d-9ccc-ca07f9234539