Anvisa clarifies the import of medical device components

News Healthcare & Pharma Guidance

Date: 10th Dec, 2024 Source: National Health Surveillance Agency (Anvisa) Country: Brazil Original Source

Brief

On October 10, 2024, the National Health Surveillance Agency (Anvisa) updated its understanding regarding Autorização de Funcionamento for importers and armazéns in Depósito Especial. The update clarifies the obligation of Autorização de Funcionamento for importing components of medical devices, excluding industrial purposes, and establishes new requirements for importing device components and accessories for commercial or repair use.

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National Health Surveillance Agency (Anvisa)

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Anvisa clarifies the import of medical device components

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Anvisa clarifies the import of medical device components

Brief

National Health Surveillance Agency (Anvisa)

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