Regulatory Focus™ > News Articles > Brazil: New Brazilian Standards For Breast Implants

Brazil: New Brazilian Standards For Breast Implants

Posted 11 April 2012 | By Louise Zornoza

The new Conformity Assessment standards for silicone in breast implants were released on 9 April by the Brazilian National Institute of Metrology, Quality and Technology (Inmetro).

The standards permit a company to choose between two different routes for obtaining Conformity Assessment.  The first involves manufacturing site certification of the Quality Management System through audits and testing of samples. The second provides for lot-by-lot certification at point of import.

Read more:

Inmetro - Inmetro publica normas para certificação de silicone

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