After product approval activities in China, not only in term of post market

Active and reactive regulatory action

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.

There are 3 Chinese identifications which are unique if you wish to place medical device in China.

1.      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.

2.      Unique Device Identifier (UDI) is a new tracing number on medical device and packaging which is in a rapid international implementation period. At the moment only UDI-DI and attributes related to approved medical device (class III and partly class II) shall be listed after approval in UDI-database in China by manufacturer’s legal representative.

3.      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.

Actually we strongly recommend backing up new electronic product certificate with annex Product Technical Requirement. (PTR). Please prove again PTR which is finalised during the Chinese type testing. These parameters on PTR are not only important during the registration, but also for tender at sales and should be frozen in design for approved medical device.

Any significant change to these parameters triggers change registration. Normally this approved medical device is a country variant which might be different than the home country variant. In QM system if this variant is chosen to be sold in China, only components which are described or not in conflict with registration dossier should be assembled and produced.

After pre-market registration begins potential inspection by health institutions and post-market activities by manufacturers

After distribution of medical device to end user in China, it begins automatically the post market activities 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 end 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 check in Chinese market placed medical device and IVD.

The legal manufacturer himself 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.

1. 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 certificate 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 standard inspection of quality system. Besides it, in term of sample inspection the authority in China can also send the subject device to certified lab to test compliant to design.

Be aware that in the Chinese life cycle at supply chain, authority has each year focused products to be inspected and applicable testing items in Chinese standards.

Pay attention under general inspection to guideline of quality management system, however there is additional guideline for IVD, implant and sterile medical device.

Mainly it applied only approved class II and III medical device. The scope of inspection by Chinese authority is similar to ISO 13485:

•          Organisation and personal

•          plant, facilities, equipment

•          Document management

•          Design and development

•          Purchase

•          Production

•          Quality Control

After pandemic NMPA starts overseas inspection personally as of 2024.

2. 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. 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. So the sum of analysed SAE is

active SAE in China and active SAE international by overseas manufacturers

+

active SAE by Chinese agent and distributor

+

reactive correct SAE and incorrect adverse events or complaints by health users

3. 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.

Have a close look at our template.

4. 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 as of 2023.

It applies only to approved medical devices in China, one report for all products.

For foreign manufacturers, Chinese agent is responsible to submit this annual report every year before April. Besides the basic info of approved medical device, following chapters are needed:

·        Change of design, material, critical components, critical production process, quality control

·        Adverse events and recalls

·        Non-conforming devices

·        All kinds of national inspections

·        Central procurement

·        Penalties

·        Internal audit

Contact us to have a bilingual annual report. One is for your back up. The other can be used by your local representative ready to submit. We have record time to fill the template.

Outlook

Compared to European post market surveillance, Chinese authority is still in a generous post market manner to stipulate the inspection and reports.

There is no annual certification inspection by notified body in China. No post markets surveillance procedure must be revised and monitored in a high professional frequence as in Europe. There are no special efforts collecting generous real world clinical data to integrate to Chinese clinical evaluation which is only once to edit at next product registration.

We illustrate below the post market activities with assigned roles. Due to complex regulations and language barrier the efforts to post market are unpredictable. Often the local distributor has limited regulatory knowledge and other interest than active monitoring in Chinese marked placed medical device.

Contact us to have an adjusted post market procedure in full compliance to Chinese requirements. We can also take over of communication with your distributor for an efficient post market results.

How to handle unexpected inspection in all supply chain even overseas manufacturers and productions site? How to monitor QM-compliance of authorised Chinese production and Chinese distributor?

We are always here to accompany or execute inspection with your need.