Important Regulatory Update for Manufacturers under MDSAP in Brazil

Today, ANVISA has announced a significant regulatory development with the publication of Resolution RDC 850/2024. This regulation brings forth a crucial amendment concerning the validity period of the Brazilian Good Manufacturing Practices (BGMP) Certificate for manufacturers operating under the Medical Device Single Audit Program (MDSAP) framework. It approves the extension of BGMP certificate validity from two to four years, exclusively for manufacturers participating in the MDSAP.

Key Points from RDC 850/2024:

• The Resolution becomes effective on April 1^st, 2024;
• The extension of the BGMP certificate’s validity period allows to reduce the financial burden on companies, by elongating the interval between payments of associated certification fees in Brazil.

Important Notes to Consider:

• The 4-year validity period is contingent upon the manufacturer’s continued participation in the MDSAP program during the BGMP Certification period;
• For petitions submitted before the Resolution’s effective date but not yet published, the extended validity period will apply.
• BGMP Certificates already issued will retain their original 2-year validity. Only new certificates and renewals will benefit from the extended validity.

MDSAP certification stands as a valuable strategy for manufacturers, given that the certification process with ANVISA is expedited and now boasts an extended validity compared to BGMP certificates obtained outside the program.

At DOMO, we are dedicated to staying at the forefront of regulatory developments, ensuring our clients benefit from timely and accurate information. Stay connected with us on social media for the latest updates on key developments in the Brazilian regulatory landscape.

For further inquiries or assistance in navigating these regulatory updates, do not hesitate to reach out to our Regulatory Affairs team.