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Trade and Industry Department The Government of the Hong Kong Special Administrative Region
Brand Hong Kong - Asia world city

Commercial Information Circulars

24-hour hotline : 23 922 922

e-mail address : enquiry@tid.gov.hk

Ref : EIC 413/2

28 February 2012

Dear Sirs,

Commercial Information Circular No. 159/2012

Brazil : Conformity Certification Requirements for Needles and Syringes

The National Institute of Metrology, Standardization and Industrial Quality (INMETRO) of the Ministry of Development, Industry and Foreign Trade of Brazil issued two Directive No. 501/2011 and No. 503/2011 to establish conformity certification requirements for sterile hypodermic needles, sterile gum needles, and sterile hypodermic syringes for single use.

2.The Directives require sterile hypodermic/gum needles for single use, and sterile hypodermic syringes for single use to be certified using certification System 5 or System 7. The conformity certification for such needles and syringes must be carried out by a Product Certification Body (Organismo de Certificação de Produto, OCP) accredited by the INMETRO. 
 

3.Sterile hypodermic/gum needles for single use and sterile hypodermic syringes for single use have to comply with the applicable minimum identity and quality requirements set out in the Resolutions No. 5/2011 and No. 3/2011 respectively.
 

4.For details of the above certification requirements, traders are advised to consult their importers in Brazil and/or the above Brazilian Directives and Resolutions (in Portugese), which are available at:

Directive No. 501/2011: http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001775.pdf

Directive No. 503/2011: http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC001777.pdf

Resolution No. 3/2011: http://brasilsus.com.br/legislacoes/rdc/107288-3.html 

Resolution No. 5/2011: http://brasilsus.com.br/legislacoes/rdc/107290-3.html. 

ENQUIRIES

5.For enquiries about the content of this circular, please contact Miss S Y TANG at telephone number 2398 5405.

Yours faithfully,




(Ms Cindy CHENG)

for Director-General of Trade and Industry