19/12/2024

As of January 1, 2025, the Hong Kong Medical Device Division (MDD) is applying new rules for renewal applications for medical device registrations to be authorised. Local Responsible Person applicants must submit the renewal application for the planned medical device at least 12 weeks and up to one year before the expiry of the current registration approval, which is valid for five years.

If the Medical Device Division does not receive the renewal application within this period, it will be considered late and the Division will not process it. If the current registration expires or the Medical Device Division receives the renewal application less than 12 weeks before expiry, the applicant will have to submit a new application.

The provisions reflect the need for advance planning and an adequate shelf life to ensure continuity in the availability of Medical Devices, avoiding interruptions in supply.

These provisions are expressed in the guide ‘Overview of the Medical Device Administrative Control System – Guidance Notes: GN – 01‘, in respect of the update of Clause 5.15 of September 30, 2024.

The news about new rules for renewal applications for medical device registrations in Hong Kong from 1 January 2025 is part of ongoing regulatory updates to Hong Kong’s medical device regulatory framework. The Medical Device Division (MDD) is revising its guidance documents to improve compliance and align with international standards. In particular, procedures are being implemented to improve the device registration and renewal process, with the introduction of the new Medical Device Information System (MDIS) available in 2024 to facilitate online applications.

SOURCE: MDD Hong Kong

>>> In cooperation with partner agencies in more than 20 non-European countries, Thema carries out activities of preparation and support for the registration of Medical Devices and In Vitro Diagnostics in various countries around the world.