During the life cycle of a medical device, changes may take place from time to time. To ensure the information of the listed medical in the Medical Device Administrative Control System (MDACS) is up to date, the Local Responsible Person (LRP) has the responsibility to timely inform MDD (Medical Device Division) of any changes to the listed medical device. Thus, the Guidance Notes (GN-10) on Changes for Listed Medical Devices, issued on 30th November 2023, is intended to guide the LRP to differentiate changes to a medical device listed under the MDACS and report the changes to MDD accordingly.
Changes to medical devices can be categorized into two: major and minor. Major Changes are changes that could be expected to affect the safety, quality or performance (SQP) of a medical device, which typically may result in risks to the patient not previously identified, increase the probability of existing hazards occurring, or alter the presentation of existing or new risks to the user (may involve labelling changes or new indications for use). Whereas Minor Changes means a change that does not fall in the definition of Major Change. For details on determining the major and minor changes, please refer to the flowchart in section 4 of the GN-10.
In regards to Reporting Changes, the Local Responsible Persons (LRP) shall report any Major Change of a listed medical device by submitting a Change Application to MDD as soon as possible, and should be at least 12 weeks prior to any planned implementation. For Minor Changes, the LRP shall notify MDD within 24 weeks from the time the LRP is aware of the change.
LRPs intending to concurrently supply the original version and changed version of the listed medical device shall include in the Change Application a proposed schedule of such arrangement. The original version could only be supplied in the market concurrently if they are still in compliance with the Essential Principles of Safety and Performance of Medical Devices as stipulated in MDACS. The LRP shall ensure that appropriate mechanisms are in place for the consumers and users to differentiate and identify the changed device. Unless otherwise specified by MDD, transition to the changed version shall be completed in 24 weeks, or any time upon MDD’s instruction.
The listing of a medical device will become invalid immediately if the said medical device undergoes any changes without notifying MDD within the specified timeframe or obtaining prior approval from MDD, as appropriate. If any Major Change has been implemented without prior approval by MDD, the concerned medical device will no longer be regarded as listed under MDACS, and the LRP shall cease to supply the medical device in a way that purports that the device is still listed under MDACS (e.g. displaying the HKMD number on the outer package or making such claims in the promotional materials).
Starting from 1st January 2024, the Local Responsible Persons shall comply with the new requirements and submit the Change Applications with the revised Change Application Form. An application for change to the listed medical device shall be made on the Change Application form. The Change Application form and other guidance notes related to MDACS can be obtained from the MDD website (Department of Health | Issued Documents under MDACS (mdd.gov.hk))
References:
Guidance Notes for Changes of Listed Medical Devices (mdd.gov.hk)
Change Application Form for Listed Medical Devices