Brasília – The National Health Surveillance Agency (Anvisa) has released a new version of its Manual for the Regulation of Medical Equipment, which consolidates procedures for registration, notification, modification and revalidation of medical device authorizations. The updated document provides clearer guidance for manufacturers and importers, including detailed flowcharts, risk classification criteria and documentation requirements.

The new manual reinforces key principles of Brazil’s regulatory framework, such as the obligation for companies to hold a valid operating authorization (AFE) before starting the registration process, and the differentiation of regulatory pathways for devices ranging from low-risk (Class I) to high-risk (Class IV). It also emphasizes traceability, quality control and post-market monitoring to ensure safety throughout the product lifecycle.

According to Anvisa, the update is part of an ongoing effort to modernize health technology regulation, increase transparency and streamline approval procedures. The revised guidance aims to reduce bureaucratic bottlenecks and strengthen compliance across Brazil’s medical device industry.

Source: Anvisa

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