The Hong Kong Medical Device Division (MDD) has implemented the Medical Device Administrative Control System (MDACS) to regulate medical devices, including operating a device registration system and an adverse event reporting system.
On September 30, 2024, the MDD updated Sections 5.14 and 5.15 in the Guidance (GN-01) on the Overview of the Medical Device Administrative Control System (MDACS), covering the validity of listing approval and renewal processes.
The updates to the GN-01 guidance on the overview of MDACS are as follows:
5.14 Validity of Listing Approval
5.14.1 An approval or conditional approval for listing a device will be valid for five years.
5.15 Renewal
5.15.1 No renewal application will be processed after the existing listing expired. Submitted materials will not be returned. Applicants shall submit a new application if their existing listing expired, or the renewal application fails to reach MDD less than 12 weeks before the listing expiry.
5.15.2 The LRP (Legal Responsible Person) shall submit an application for renewal of the listing to the MDD at least 12 weeks to 1 year (both the first and last days inclusive) before the expiry of this five-year validity period. Unless the application for renewal of the listing reaches the MDD within this time frame, MDD will not proceed the renewal application.
Please refer to the attached document below.
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