“The Hong Kong MDD takes post market surveillance very seriously and high risk devices require annual submission of the recently updated form MD108e.”
Albert Pranoto
Director of Business Development, Asia Actual Singapore
Hong Kong Refines Medical Device Post-Market Surveillance Report
Published on: January 27th, 2022
Hong Kong Refines Medical Device Post-Market Surveillance Report
On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form. This action is seen as preparation ahead of transitioning compliance to the Medical Device Rules from voluntary to mandatory, and consistent with trends throughout Asia to beef up post-market vigilance requirements.
The new form is slightly more extensive and features updated language concerning the annual submission of the form for specific medical devices. The form number has been updated to MD108e and can be found on the MDD website here.
If you have any questions about Post-Market Surveillance in Hong Kong, or other ASEAN countries, please contact us here.
Hong Kong Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance is a particular focus of the MDD in Hong Kong, with close monitoring in the local market, as well as international markets. Failure to adhere to Post-Market Surveillance requirements could lead to loss of market access and/or product recall. Post-Market Surveillance in Hong Kong consists of recording and reporting adverse events or complaints, in addition to taking corrective actions as required.
The MDD requires the Local Responsible Persons (LRPs) to keep track of and report adverse events that occur related to their listed devices. Said LRP is required to get in touch with the MDCO with the details of both the situation and planned corrective actions within the span of 10 calendar days from when the manufacturer first learns of the accident.
For reference, local manufacturers, or the LRP have the following responsibilities when it comes to Post-Market Surveillance:
- Report Adverse Events as soon as they occur, within 10 calendar days if the device has been involved in a serious injury or death and within 30 days for all other cases
- Give the MDD the distribution and importation records of the device
- Maintain installation records for a period of 7 years
However, the responsibilities for manufacturers/the LRP differ for certain high-risk devices, as is specified in an MDD approval letter.
Special Reporting for High-Risk Devices
Per the MDD, certain medical devices have different reporting requirements than standard medical devices, depending on their category of risk. The following devices must submit Post-Market Surveillance forms regardless of whether an adverse event has occurred, due to the inherent risk in their usage:
- Mechanical heart valves
- Implantable pacemakers, their electrodes and leads
- Implantable defibrillators, their electrodes and leads
- Implantable ventricular support systems
- Implantable drug infusion systems
MDD Vigilance of Post-Market Vigilance Responsibilities
One of our responsibilities at Asia Actual is acting as a local responsible person in Hong Kong for manufacturers. At Asia Actual we have seen firsthand the seriousness the Hong Kong MDD takes post-market vigilance globally. On one occasion, we were contacted after an adverse event had occurred in Hong Kong regarding a product we had registered in Singapore. Such is the gravity the MDD takes when ensuring the post-market safety of products licensed in Hong Kong.
As a registered and active Local Responsible Person in Hong Kong, Asia Actual has been contacted by the MDD regarding adverse events that occurred for devices for which Asia Actual was the license holder in another market, but not Hong Kong. This is clear evidence of the extent to which the MDD monitors adverse event reporting outside Hong Kong’s borders.
Come Grow With Us
Asia Actual has an office in Hong Kong staffed by experienced, bilingual regulatory and commercial professionals to address any questions or provide support. Please contact us to explore if this new program is appropriate for your devices.
Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfillment, and a variety of sales channel support services.
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