Hong Kong Medical Device Division (MDD) issued formal guidance (GN-10 Guidance Notes on Changes for Listed Medical Devices) on the requirements to maintain compliance when making changes to a medical device registered with the Medical Device Administrative Control System (MDACS).
The GN-10 guidelines include classification of whether changes to registered medical devices are major or minor and management of changes. GN-10 guidance will take effect on January 1, 2024.
Major Change means a change that could be expected to affect the safety, quality or performance (SQP) of a medical device.
- result in risks to the patient not previously identified
- increase the probability of existing hazards occurring
- alter the presentation of existing or new risks to the user (may involve labelling changes or new indications for use)
Minor Change means a change that does not fall in the definition of Major Change.
In the GN-10 guidelines, the change classification (Major, Minor) decision was divided into eight flowcharts.
Flowchart: Decision on categorisation of changes
4.3(a) Main Flowchart General Changes made to Medical Devices
4.3(b) Flowchart A Changes in Manufacturing Processes, Facility or Quality Management System (including Quality Control, QC)
4.3(c) Flowchart B Changes in Design for Medical Devices
4.3(d) Flowchart C Changes to Sterilisation Facility and its Process or Quality Management System
4.3(e) Flowchart D Changes to Software for Medical Devices
4.3(f) Flowchart E Changes in Materials for General Medical Devices
4.3(g) Flowchart F Changes in Materials for In Vitro Diagnostic (IVD) Medical Devices
4.3(h) Flowchart G Changes to Labelling or Special Listing Information
Through this classification flowchart, Major Change of a listed medical device 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.
Please refer to the file below for details.
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