. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/366 
23 February 2010  
 (10-0971) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance 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, Standa rdization and Industrial Quality-INMETRO 
Telephone:  +(55) 21 25632821 Telefax:  +(55) 21 25026542 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):  Sterile hypodermic 
needles for single use.  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 10, 
27 January 2010 – sterile hypodermic needles for single use (4 pages, Portuguese) 
6. Description of content:  This technical regulati on establishes the minimum requirements of 
identity and quality of sterile hypodermic needles for single use, as specified in the Annex of 
the Resolution.  
Sterile hypodermic needles must also meet the requirements for certification under the 
Brazilian Conformity As sessment System (SBAC). 
According to the paragraph of Art. 2,  dome stic manufacturers and importers may choose the 
type of certification under the SBAC.  
The companies have a period of 180 days to adequate to the Resolution, after its entry into 
force.  
The Resolution is based on the Internationa l Standard ISO 7864:1993 – Sterile hypodermic 
needles for single use; and on the followi ng standards: ABNT, NBR Nº 5426:1985; ABNT, 
NBR 9259:1997; ABNT, NBR 9626:2003; AB NT, NBR 5601:1981; ABNT, NBR ISO 
nº 594-1:2003; ABNT, NBR ISO Nº 594-2:2003.   G/TBT/N/BRA/366 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da União), 1 February 2010; 
Section 1. Draft Resolution (Consulta Públic a) number 10, 27 January 2010, issued by 
Brazilian Sanitary Surveillance Agency – A nvisa; When adopted, it will be published at 
Brazilian Official Journal. Available in Portuguese.   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period.  
On the date of adoption. 
10. Final date for comments:  1 April 2010 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
Agency responsible 
Brazilian Sanitary 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  Website:  http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br /wps/wcm/connect/19acae 804138865abbb7bfc5ae04202e/CP+N%
C2%BA+10+GGTPS.pdf?MOD=AJPERES