Post-market Surveillance (Part 1)

One of the disastrous scandals in the medical device industry happened in 2010.

That was the Poly Implant Prothèse (PIP) breast implant scandal. Industrial-grade silicone was illegally used instead of approved medical-grade silicone in the breast implants.

PIP implants had a higher rate of ruptures than standard silicone implants. This affected more than 100,000 women worldwide.

The scandal highlighted flaws in the regulatory system.

This triggers the need to strengthen the post-market surveillance, quality control of medical devices, and oversight of notified bodies.

Marketing authorization is not the final destination, but a starting point for monitoring activities.

There is no single medical device that is risk-free.

Approved ≠ 100 % safe.

The manufacturer bears the responsibility to continuously monitor the safety, effectiveness, and quality of the medical device during its lifetime.

This includes after-sales. The problem arises when post-market surveillance (PMS) is not properly implemented!

What does NMPA require you to fulfill PMS in China?

What are the obligations as a registration holder?

Each country may have a different set of post-market requirements and obligations. As a registration holder of an approved product, you must fulfil the following key obligations in China:

• Establish a quality management system (QMS) that oversees the processes for adverse events (AE) monitoring and re-evaluation.

• Have a dedicated team and personnel appropriate to its products to monitor medical device adverse events.

• Collect and report medical device adverse events to the competent agencies promptly following the stipulated timeframes. Cooperate upon request.

• Investigate and analyze adverse events, as well as take proper measures to control risks in a timely manner.

• Conduct continuous research on the safety of approved medical devices and compile periodic risk evaluation reports.

• Proactively perform re-evaluation of medical devices.

What type of PMS activities are in China?

You may be familiar with the PMS, Periodic Safety Update Report (PSUR), Post-market Clinical Follow-up (PMCF) from EU Medical Device Regulation (MDR).

But, these do not fully fulfill the PMS requirements in China. Although you can use some information from PSUR, China needs additional types of data.

Based on the responsibilities, we can categorize them into three pillars of China’s PMS.

1) QMS evaluation on the processes concerning the design control and PMS

2) Risk evaluation of the product lifecycle

3) Re-evaluation of the product safety and effectiveness

Today I’ll only go through the 1st point. The rest will follow in the upcoming series of Part 2 and 3.

What does China require for QMS evaluation?

The registration holder of the medical device shall compile an Annual QMS Self-inspection Report based on the internal evaluation of the QMS aspects.

This includes information about significant changes of the product design, raw materials, audit history, internal and external audits, and post-market control of the products that have obtained marketing approval in China.

You need the data of customer complaints, recall, sampling check, product non-conformity, AE records and monitoring in the post-market control segments.

Some data overlap with the information required in PSUR as well. So it is not too bad!

Registration-relevant information, such as Product Technical Requirements (PTR), authorized representative, and sales status of the products is also required.

Having issues with your PMS in China? Write me and we can have a call.

When should you submit?

The registration holder must compile this information every year as soon as the product has been approved.

The period of data collection is between January 1^st to December 31^st of the previous year, starting from the date when you acquire marketing approval.

The submission deadline is March 31^st every year.

You need to provide relevant data until the date your registration runs out or you withdraw the approval from the market.

China will run after you until you are done. Indefinitely.

How do you submit the report?

If you are a registration holder of the imported medical device, your appointed in-country representative shall submit on your behalf.

This falls within the scope of the responsibilities of the authorized representative to support the foreign registration holder. The authorized representative is responsible for the communication and data transmission of the report to the MAERS database of NMPA.

Only legal entities within the medical device business can access the Medical Adverse Events Reporting System (MAERS). The foreign registration holder does not have access to the platform.

If you have multiple approved devices, you can complete and submit them in one report.

Miss the deadline? Don’t panic and submit as soon as you can to avoid a non-compliance or a penalty warning.

Hope that you have done your PMS correctly. If not, feel free to email me at [email protected] or send me a direct message via LinkedIn.

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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.