Design & Development Controls

For medical device manufacturers that design devices (not just manufacturers of licensed designs), RDC 752/2022 requires a documented design and development process covering:

Design and development planning — stages, reviews, responsibilities;
Design inputs — functional, performance, safety, regulatory, and user requirements;
Design outputs — specifications, drawings, manufacturing procedures;
Design review — formal reviews at planned stages;
Design verification — confirming outputs meet inputs (testing, analysis, inspection);
Design validation — confirming the final device meets user needs and intended use;
Design changes — controlled change management throughout the product lifecycle; and
Design transfer — ensuring the design is correctly transferred to production.

The Design History File (DHF) must be maintained and available to ANVISA inspectors.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

The Design History File must include all design planning documents, design input specifications, design output documentation, design review meeting minutes, verification and validation reports, and design change records. The DHF must be retained for the lifetime of the device plus a minimum of 5 years after the device is removed from the market.