Brasília – The National Health Surveillance Agency (Anvisa) published Call for Proposals No. 22/2025 on Monday (10), inviting companies with primary regulatory filings (in Notification or Registration regimes) for medical-devices that remain “awaiting analysis” to submit data identifying whether such devices are identical to ones already approved and by other companies.

The initiative is aimed at optimising regulatory workflows and shrinking queues: by using information to identify duplicates or cases where a device has already been evaluated favourably, Anvisa expects to reduce review times and support faster access to devices in Brazil. The form will remain open for 45 days.

Source: Anvisa


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