Post-market Surveillance (Part 2)

Post-market surveillance (PMS) has a crucial mission. It allows the continuous monitoring of the safety and performance of medical devices after they hit the market.

Medical devices go through rigorous testing, product validation, and pre-market approval.

In fact, we are unable to cover all potential risks when launching a new device.

Which jurisdiction has the world’s most demanding PMS regime?

It is not China (Not yet!). The EU Medical Device Regulation (MDR) is the current gold standard (and toughest) PMS for the medical device industry.

It requires a proactive lifecycle oversight approach through PMS, PSUR, trend reporting, PMCF evaluation…

Although the EU MDR has the most rigorous PMS framework worldwide, it is insufficient to cover a single jurisdiction.

Do you have a process in place that covers the China PMS?

Some foreign manufacturers do not implement the PMS process, as China isn’t the main market. As a consequence, the authorized representative faces a penalty.

The surveillance has been tightening in recent years, so don’t let this happen to you.

Last week, I covered a fundamental introduction and the most important part of China’s PMS - Annual QMS Self-inspection Report.

This week highlights the requirements for the risk evaluation as part of China’s PMS.

🍜 Requirements of China’s Risk Evaluation

The registration holder of the product approval shall continuously monitor the safety and risks of marketed medical devices throughout the product lifecycle.

This applies to all registration holders of medical device approval. The compilation of the Periodic Risk Evaluation Report (PRER) is compulsory.

This report shall include data on domestic and international adverse events and risk information, literature data, risk-benefit analysis, process and complaint evaluation, as well as risk control measures.

Each marketing approval (device with accessories - if applicable) should have its PRER.

Some required information overlaps with PSUR if you are familiar with the PSUR from the EU MDR.

However, the data collection period of PSUR depends on the MDR certification date and the MDR Date of Application. The period varies based on risk class.

It does not align with the data collection period of PRER. A separate PMS procedure for China is needed.

Need help with your PMS? Feel free to send me your questions.

🍜 Submission Frequency and Deadline

The period of data collection for PRER depends on when you receive marketing approval. Unlike the Annual QMS Self-inspection Report, the submission deadline is variable.

You shall complete and submit the report for the previous year within 60 days after the first anniversary of the product's initial approval.

For example, you acquired the market approval in August 2024. Your first submission deadline is in October 2025.

You have an extra 2 months to prepare the report for the last 12 months. To simplify, each annual reporting deadline is 14 months apart.

The submission is on a yearly basis for the first 5 years.

You can think of this as “trial years”. There is a higher chance that adverse events and incidents will occur in the first few years, as the products are new to the market.

Once you have successfully extended your marketing approval, the frequency of the subsequent PRER submission is adjusted to every 5 years.

This means you need to cover 5 years’ data in one report when applying for the next approval extension.

🍜 Submission Method

As a registration holder of the imported medical device, you do not have access to the Medical Adverse Events Reporting System (MAERS) in China.

In this case, the authorized representative of your product registration shall submit the annual reports on your behalf to the MAERS database.

This applies to registration holders of Class II and Class III medical devices. The submission of PRER is optional for Class I medical devices.

However, you shall ensure that the reports are available upon request for inspection by the authority.

Getting stuck with your PRER? Send me an email or dm me on LinkedIn.

🍜 Recommended Reading

The UK MHRA published an amendment to the Medical Devices (Post-market Surveillance Requirements) that goes into effect on June 16^th , 2025.

The deadline is fast-approaching, so don’t forget to update your internal process.

Monir @Easy Medical Device outlined a roadmap about how to deal with the new UK PMS Requirements.

Disclaimer: This content is created solely in my personal interest and does not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for informational purposes and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.