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Brazil: ANVISA Announces to Extend B-GMP Certificates for MDSAP-Certified Medical Device Manufacturers (w.e.f 1 April 2024)

On 20 March 2024, ANVISA published Resolution RDC 850/2024 with an official announcement to extend the Brazil Good Manufacturing Practices (B-GMP) Certificate from two (2) to four (4) years applicable to all medical device manufacturers under the Medical Device Single Audit Program (MDSAP).


This enforcement enters into force on 1 April 2024 and it will only benefit the new certificates issued and any B-GMP certificate holders undergoing renewal requests waiting for ANVISA approval before enforcing the Resolution. Hence, those manufacturers with 2-year B-GMP certificate issuance will remain the same until the next renewal.


Class III and IV medical device manufacturers were required to obtain a B-GMP certificate in Brazil. The certificate extension helps manufacturers reduce their regulatory fees and also enhances the benefits of the MDSAP certification.

 


Contact us at info@arqon.com for more information.

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