ARTICLE SUMMARY:
The new framework that took effect June 1 doesn’t seek to establish new GMP requirements, but to clarify and in some cases streamline what is expected for manufacturers of higher risk devices that are sold in Brazil.
A new resolution outlining Brazil ANVISA’s procedures for assessing and granting good manufacturing practice (GMP) certifications to device manufacturers took effect June 1.
Device makers must have a current certification (called CBPF) to market Class III and IV devices in Brazil. The new rule replaces a 2017 document.
ANVISA isn’t staking out new requirements in the update, but it is primarily focused on clarifying its GMP expectations. The new guidelines tease out what documentation is required based on whether a manufacturer is domestic to Brazil, whether it is located in a Mercosur country (a South America-based trade block), or elsewhere but participating in a shared audit program (e.g., the Medical Device Single Audit Program, MDSAP).
The resolution also clarifies and streamlines which documents are necessary to renew a certification. And it explains three distinct routes to gaining a new or renewed certification that involve different combinations of audit reports (from ANVISA or an accredited third party), fulfilling documentation requirements, and undergoing a risk analysis that takes into consideration multiple factors including the technologies made at the facility and the complexity of the manufacturing unit.
ANVISA also for the first time published a “risk matrix” to provide more transparency about how ANVISA weighs risk for an array of manufacturing considerations. For instance, the matrix affirms a plant that makes devices with related technologies may be higher risk than facilities that manufacturer devices with a more diverse range of technology types.
Trial MyStrategist.com and unlock 7-days of exclusive subscriber-only access to the medical device industry's most trusted strategic publications: MedTech Strategist & Market Pathways. For more information on our demographics and current readership click here.