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  • Brazil: New Brazilian Standards For Breast Implants

    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 a...
  • Brazil's Anvisa Introduces Additional Controls on Breast Implant Products

    Brazilian regulatory authority Anvisa this week became the latest health regulator to exercise greater enforcement controls over the sale and testing of breast implant products in the wake of a global scandal, reports Reuters . "Health regulator Anvisa will require implants to be certified through the national quality control institute Inmetro to ensure products meet new criteria including physical strength, tear resistance and absence of toxic substances," wrote Reute...