Session 3.0 Post market surveillance
1. Learning objective
Since there is no certification cycle for imported medical device in term of quality system, the only task for QM is actually after product approval. In this session we will also learn Chinese Post market surveillance.
2. Video
3. Post market surveillance and quality management system in China
a. Registration related after approval activities
After successful product approval, legal manufacturers should finalize Chinese labelling, register Unique Device Identifier (UDI) and Medical insurance medical consumables code. Besides the design change in the whole lifecycle of product should be assessed.
- Chinese Labelling are Chinese IFU and Chinese label meant. After product approval, NMPA issues a certification number on certificate which should be revised in submitted draft of Chinese IFU and Chinese label. Special for Chinese label is production date which should not be older than approval date.
- Unique Device Identifier (UDI) is a new tracing number on medical device and packaging which is in a rapid international implementation period. Only UDI-DI and attributes related to approved medical device shall be listed after approval in UDI-database in China by manufacturer’s legal representative.
- Medical insurance medical consumables code is unique Chinese in insurance system. The Chinese legal representative should register UDI and Medical insurance medical consumables code in insurance databases.
- Analysis of product change. Actually after submission the significant change of subject product should be frozen and analysed in the whole lifecycle of medical device.
b. Post market surveillance and quality system
After distribution of medical device to user in China, it begins automatically the post market surveillance in the whole supplier chain which should be described in QM-procedure and recorded compliant to Chinese requirements. The Chinese authority has the right to inspect legal manufacturers, Chinese agent of foreign manufacturers, all levels of distributors and users (normally hospitals), which can be seen as a kind of reactive post-market activities. Even the customs for foreign manufacturers, local health authorities, hospitals could monitor and prove in Chinese market placed medical device and IVD. The legal manufacturers should actively collect all product data to fulfil their post-market activities (active post-market activities) as complaint, reporting of adverse event and recalls, periodic risk evaluation report, annual report of quality management.
Potential reactive inspection
Fortunately the manufacturers for medical device produced outside China don’t need pass the Chinese GMP-inspection. Normally at product registration a valid ISO 13485 is the best evidence for guaranteed QM-requirement. Unfortunately after product approval, Chinese authority may audit all stakeholders in supply chain, from Chinese agent, distributor, hospitals, often ignored is also overseas inspection of foreign factory. Normally there is inspection of quality system. Besides it, in term of sample inspection the authority can also send the subject device to certified lab to test compliant to requirements.
(Serious) adverse event and recall
The subjects to submit report to Chinese authority are serious adverse event and recall (over the world).
To record on manufacturers own quality management are typically: normal adverse event, customer complaints and unsolicited user feedback.
It means only serious injuries are obligatorily to report in theory. It makes reporting system complicated that more and more health users register for an event of adverse event in central database without communicating with legal manufacturers.
Periodic Risk Evaluation Report
It is quasi Chinese PSUR. It is annually to submit in the first 5 years Chinese lifecycle after approval.
The authority provides a relative clear template for manufacturers. It contains worldwide marketing history, vigilance summary, literature evaluation and risk analysis related to adverse effects, adverse events and recalls.
Annual QM report (new in 2023)
Perhaps the Chinese authority can`t oversea foreign manufacturers in the quality and production aspects, perhaps Chinese authority learns from other markets there is also QM-reports regularly. Invented is annual self-examination report of medical device quality management system.
For foreign manufacturers, Chinese agent is responsible to submit this annual report every year before April.
c. Assigned role for post market surveillance quality system in QM
