Brasília – The National Health Surveillance Agency (Anvisa) and the Brazilian Association of Importers and Distributors of Health Products (Abraidi) held the 5th International Seminar on Medical Devices in São Paulo on August 27–28. Conducted in hybrid format (in-person and online), the event featured simultaneous translation in English and Spanish and attracted participants from across Latin America.

Karen Noffs, General Manager of the Medical Device Technology Division at Anvisa, highlighted the shared commitment between regulators and industry to safeguard public health through rigorous documentation and safety testing. Thiago Rezende Cunha, from Anvisa’s Medical Device Steering Committee, discussed regulatory structures and engagement with international forums like the IMDRF and the Medical Device Single Audit Program (MDSAP).

Noffs also shared data revealing that 32% of medical devices reviewed are manufactured in Brazil, while 68% are imported—mainly from the U.S., China, and other countries. She noted a steady annual growth in device registrations and called for expanding Anvisa’s workforce to speed up analysis. She further announced the creation of a Technical Chamber for Medical Devices, modeled after the one for pharmaceuticals, to support decisions on novel products and advance regulatory convergence.

Source: Anvisa

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