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Scrip Regulatory Affairs
Brazilian GMP certificates will soon be compulsory
26 February 2010
Vibha Sharma

The Brazilian Health Surveillance Agency, ANVISA, will implement from 22 May new requirements for local and foreign manufacturers of certain medical devices to comply with Brazilian good manufacturing practices.

The GMP requirements will apply to manufacturers of high-risk medical equipment (Classes III and IV) as well as high-risk in vitro diagnostics (Classes II, III and IIIa), notes Evangeline Loh, vice president (regulatory affairs) at consultancy firm Emergo Group1,2...

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