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Proposed Extension of BGMP Certificate’s Validity: Navigating Regulatory Efficiency with MDSAP
Date: 11/28/2023
Public Consultation No. 1.208 will be open to receive contributions until December 9th.
In the dynamic landscape of medical device regulations in Brazil, obtaining the Brazilian Good Manufacturing Practices (BGMP) certification is a mandatory request for manufacturers of Class III and Class IV devices seeking Registro.
In a recent move towards regulatory efficiency, ANVISA introduced a Public Consultation (Consulta Pública n° 1.208, October 16, 2023) proposing the extension of BGMP certificates validity from two to four years for manufacturers participating on the MDSAP program.
The consultation period invites stakeholders to contribute their perspectives on this potential regulatory amendment. If approved, the change would signify a strategic shift, amplifying the benefits of an MDSAP certified manufacturer, contingent upon the maintenance of participation in the MDSAP program during the term of the BGMP certificate.
The Medical Device Single Audit Program (MDSAP) represents a stride towards regulatory convergence, fostering greater global alignment based on international best practice standards and streamlining health regulation. The program’s efficiency is evident in the prompt application of Good Manufacturing Practices, frequently achieved exclusively through document analysis, possibly eliminating the necessity for a new audit by ANVISA. The manufacturer’s MDSAP certification provides a streamlined pathway for the granting and renewal of the BGMP certificate, thereby expediting the process of product registration and commercialization in Brazil.
The new proposal may allow for a reduction in the financial burden on companies, as the extension of the certificate’s validity will result in a longer interval between payments of fees associated with the certification process.
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