Post Market Surveillance is required for manufacturers selling medical devices in Hong Kong and failure to comply could lead to a product recall and/or loss of market access. Post Market Surveillance in Hong Kong consists of recording and reporting adverse events along with taking corrective actions if needed.
Under the Medical Device Administrative Control System (MDACS), Local Responsible Persons (LRPs) are required to report and manage adverse events occurring in Hong Kong concerning any of their listed devices. The LRP must notify the MDCO of the related details and actions to be taken in Hong Kong within 10 calendar days from when the manufacturer first initiates actions.
Incidents occurring outside Hong Kong do not need to be reported.
Record Keeping and Adverse Events
Adverse Events are reported through the Medical Device Adverse Incident Reporting System and Reporting Forms can be found here.
In general, Manufacturers and their LRP are obligated to:
report Adverse Events as soon as possible, not later than 10 calendar days for death or serious injury, and not later than 30 days for all others.
provide the distribution record and importation records of the device to MDD when there is a request. We will let you know when we are asked to provide and which your distributor has to share the records to us within 48 hours after a request has been made.
maintain installation records for 7 years, as required.
inform MDD as soon as possible should there be any recalls or adverse events.
Below are some of the highlights from the Guidance Notes (GN-03) for Adverse Incident Reporting
4.1 Any incident that led to one of the following outcomes is considered a Reportable Event:
Death of a patient, user or other person;
Serious injury of a patient, user or other person;
No death or serious injury occurred but the incident might lead to death or
serious injury of a patient, user or other person if the incident recurs.
4.2 User errors meeting any of the following criteria are also reportable:
Use error that results in death or serious injury / serious public health concern.
When the LRP or manufacturer notes a change in trend or a change in pattern of an issue that can potentially lead to death or serious injury or public health
When the LRP or manufacturer initiates corrective action to prevent death or serious injury or serious public health concern.
Field Safety Corrective Actions
Field Safety Corrective Action means corrective action taken by the manufacturer for technical or medical reasons to prevent from or reduce the risk of a serious incident in relation to a device made available on the market. This may include:
The return of a medical device to the manufacturer or its representative;
Device disposal; or
Advice given by manufacturer regarding the use of the device.
What Actions will the HK Department of Health (DH) take upon receiving reports of an Adverse Event?
The DH will closely monitor the investigation done by the local supplier and the manufacturer. The investigation reports may reveal unexpected problems related to the medical device, which can lead to actions including but not limited to product recall, revision of user manual, and device modification. The DH will monitor the corrective and preventive actions that are being implemented to prevent similar events from recurring.
Contact Asia Actual with questions regarding Hong Kong Post Market Surveillance. Our local, bi-lingual regulatory experts are well positioned to assist.