Global Directory ( β-Version )

The Global Directory of Registered AI in Healthcare will consolidate regulatory information on AI-related and registered medical devices into a single, global, and transparent database. It is being developed in collaboration with regulatory authorities from our Global Regulatory Network,with pioneering member countries taking a leading role in shaping and co-creating the beta version during Q4 2025.

Visit the Directory ⭷ ( β testers only)
Global Directory ( β-Version )

FAQ Directory

More details on the purpose and status of HealthAI directory

What kind of Solutions will be displayed on the directory ?

The Directory will focus exclusively on medical and healthcare solutions that are made with or contain AI components and have been approved by national regulatory authorities (e.g., FDA-cleared or CE-marked devices). Solutions still under review are excluded.
A distinctive feature of the Directory will be its ability to track approval status across multiple jurisdictions and to provide a standardized descriptive framework for the AI components.

 

What is the current development status of the Directory ?

As of Q3 2025, HealthAI is developing a functional beta version that integrates data from the FDA GUDID. Integration of additional countries’ data is planned for Q4 2025 and throughout 2026, as new authorities join our Global Regulatory Network (GRN).
Currently, access to the beta Directory is granted exclusively to pioneering GRN member authorities, who are invited to take a leading role in co-creating the platform.

Who will be maintaining and updating the directory ?

GRN member authorities will contribute and maintain their own national data, which will be mirrored on the global Directory to provide broader visibility. HealthAI will ensure the overall integrity of the database and validate major updates before they are published. In addition, HealthAI will provide the technical infrastructure, documentation, and support needed for authorities’ IT teams to establish secure data connections and automate updates to the Directory.

How can I participate ?

If you are part of a regulatory authority, your country and institution can join our Global regulatory network.