Hong Kong: Revised Guidelines for Processing Application Renewal of Listed Medical Device (w.e.f 1 January 2025)

On 30 September 2024, the Medical Device Division (MDD) of Hong Kong introduced an updated procedure for processing renewal applications for Listed Medical Devices. Effective 1 January 2025, MDD will no longer process renewal applications that are submitted less than 12 weeks before the device’s listing expiry.

There are 2 revisions made which are: Validity of Listing Approval (Clause 5.14) and Renewal (Clause 5.15). Stakeholders can find further details on the arrangement in the Guidance Notes (GN-01).

Validity of Listing Approval

The MDD permits a validity period of up to five (5) years for the approval or conditional approval of a listed medical device.

Renewal

• No renewal application will be processed after the existing listing expires. Applications submitted including materials will not be returned and applicants shall submit a new renewal application. Applicants must ensure the applications are received by MDD not less than 12 weeks before the listing expiry.

• Local Responsible Person (LRP) shall submit a renewal application for the listing to MDD at least 12 weeks to 1 year (both the first and last days inclusive) before the 5-year validity period expires. MDD will not process the renewal application unless the application reaches MDD within the timeframe.

These changes emphasized the importance of timely submissions to ensure continuous listing and compliance, reinforcing MDD’s commitment to maintaining stringent regulatory standards within the medical device industry.

Source: Medical Device Division (MDD)