  
  
G/TBT/N/BRA/914  
24 September 2019  
(19-6131) 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 2563.2918  
Telefax: +(55) 21 2563.5637  
Email: barreirastecnicas@inmetro.gov.br   
Web-site: www.inmetro.gov.br/barreirastecnicas  
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 differ ent from above:   
Brazilian Health Regulatory 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):  
HS Code(s): 901831 (Sterile hypodermic syringes for single use)  
5. Title, number of pages and language(s) of the notified document:  Draft resolution 
number 709, September 16th, 2019. (6 page(s), in Portuguese)  
6. Description of content:  This draft resolution proposes the revision of the Resolution – 
RDC number 3, 4 February 2011, which establishes the minimum requirements of quality 
and identity for Sterile hypodermic syringes for single use.  
Comment form: http://form sus.datasus.gov.br/site/formulario.php?id_aplicacao=50280  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  Protection of Human Healt h 
8. Relevant documents:   
• Resolution – RDC number 3, February 4th, 2011   
9. Proposed date of adoption:  To be determined after the end of the consultation per iod. 
Proposed date of entry into force:  In the date of its publication.  
10. Final date for comments:  8 November 2019  G/TBT/N/BRA/914  
 
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  11. Texts available from:  National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
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/10181/5635986/Consulta+P%C3%BAblica+n%C
2%BA+709 -2019.pdf/05cdf637 -8937-41c6-adbd-14af837544 c2 
 