Hong Kong: MDD Releases GN-10 - Changes Guide for Listed Medical Devices (1 January 2024)

The Medical Device Division (MDD) issued a guidance, “Guidance Notes on Changes for Listed Medical Device (GN-10)” to guide the Local Representative Person (LRP) in categorizing, managing, and reporting the changes related to the listed medical devices under MDACS. LRP should start complying with the new requirements from 1 January 2024.

Changes intended in the guidance are divided into 2 types: Major Change and Minor Change.

Major Change refers to any changes that would affect the safety, quality, and performance (SQP) of the medical device, which also LRP should take note of any possibility of:

• The result in risks to the patient that were not previously identified

• Probability increments of the existing hazards that may occur

• Alteration to the presentation of existing or new risks to the user (may involve labeling changes or new indications for use)

The listing will be invalid if the medical device undergoes any changes without notifying the MDD. For any Major Change without notifying the MDD, the medical device will be removed from the listed medical devices under MDACS and LRP should cease all medical device supply.

Reporting Changes

Supply of Changed Medical Devices

LRP should be responsible for ensuring the proposed schedule must be included in the Change Application, for supplying both the original and changed version of the medical device concurrently. The original version is allowed to be supplied only if still able to comply with the Essential Principles of Safety and Performance of Medical Devices by MDACS. Otherwise, 24 weeks is given as the transition period to the changed version, or period stated by the MDD.

Application Procedures

• LRP should submit any changes for the listed medical device by using the Change Application form to the MDD, via email, by hand, or by mail

• MDD will acknowledge the submission upon receipt and LRP may enquire to MDD within 2 weeks for submission confirmation

• It is upon the discretion of MDD to request for new listing submission or proceed with the change application, depending on the circumstances and information submitted

• MDD would not accept multiple submissions of the same device while the previous submission is under evaluation review.

• LRP should withdraw the previous Change Application that is under evaluation and submit a new Change Application including all changes and supporting documents (for unavoidable cases)

• LRP should not proceed with any changes if the application is rejected, otherwise, the listing status will be invalid

• LRP should request for replacement of the Listing Certificate by returning the original copy to the MDD (for necessary issuance)

LRP may refer to the guidance here for detailed flowcharts of situations to determine the major or minor changes needed for the listed medical devices

Source: Medical Device Division (MDD)

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