Each year, the FDA receives more than 2 million incident or adverse event (AE) reports related to medical devices in the U.S.

That’s about the entire population of Slovenia. Imagine every Slovene filing a report. It’s a massive number.

In China, however, the National Medical Products Administration (NMPA) received only > 780,000 adverse event reports in 2023. Where does the gap come from?

Some companies don’t fully fulfill their reporting duties. Additionally, weak enforcement further exacerbates the situation.

To close this gap, the NMPA rolled out stricter post-market surveillance (PMS) rules. Registration holders are expected to take a much more active role.

Re-evaluation of marketed medical devices became mandatory.

Check out Part 1 (Annual QMS Self-inspection) and Part 2 (Periodic Risk Evaluation) of China’s PMS framework in case you missed them.

🍜 When Is Reassessment Needed?

Medical device reassessment means keeping track of its safety and effectiveness, while acting fast when new risks come up.

You’ll need to reassess your device marketed in China in these three situations:

When science and technology move forward

New research or breakthroughs can change what’s considered state-of-the-art and shift the current understanding of safety and effectiveness.

When AEs indicate potential defects

Analyzing AE data may reveal hidden or unexpected risks. It's time to reevaluate if those risks outweigh the device’s benefits.

When the NMPA gives instructions

Sometimes, the NMPA directly calls for reassessment. Especially if there's a spike in AEs linked to similar devices on the market.

Always stay alert by tracking industry trends and strengthening your risk management systems before regulations come knocking.

It’s not only about staying compliant. If done right, these steps protect your business from headaches and unnecessary costs down the road.

🍜 What Are The Requirements?

When reassessing your medical device, you have to gather comprehensive post-market data.

This includes clinical performance, safety and effectiveness, usability, and other information from reliable sources.

Based on what you find, you may need to update technical documentation, research data, clinical evaluation, risk assessment, product technical requirements (PTR), instructions for use, and labeling.

Your re-evaluation report should cover:

• Risk-benefit analysis

• Socio-economic impacts

• State-of-the-art technology

• Relevant risk control measures

You must implement effective risk controls to reduce risks to an acceptable level if you uncover serious safety concerns or product defects.

If that isn’t possible, you should voluntarily withdraw your registration.

NMPA also has the authority to revoke registrations or phase out approved products.

This happens if they reckon that your risk controls are not effective, or if continued use could harm patients.

In that case, you must immediately stop production, sales, and distribution. A recall will follow if needed.

To reverse this action, you'll have to conduct another reassessment.

🍜 Reporting Timelines

A reassessment can either be voluntary or required by the NMPA.

Voluntary reassessment

If you identify that risk-control measures are necessary, you must submit a reassessment report within 15 calendar days after reaching that conclusion.

NMPA-driven reassessment

If NMPA requests a reassessment, you must:

• Submit a reassessment plan at least 30 calendar days before starting the reassessment.

• Submit the final report within 30 calendar days once the reassessment has been completed.

If your reassessment takes more than a year, you must keep NMPA updated through an annual report.

When NMPA initiates reassessment, it usually means the monitoring system has raised red flags. Staying proactive is the best way to avoid surprises.

When NMPA initiates reassessment, it usually means that the monitoring agency suspects red flags.

🍜 How To Submit Your Report?

Just like the Annual QMS self-evaluation report and PRER, your authorized representative must upload re-evaluation reports into the Medical Adverse Events Reporting System (MAERS).

MAERS is not publicly accessible. Only local entities and hospitals in China can log in, report, and retrieve adverse events.

As a foreign registration holder, you rely entirely on your local representative. This makes your choice of representative critical.

You need a partner who is not only reliable but also knowledgeable in navigating NMPA’s systems.

Still have questions? Feel free to reach out to me via email or LinkedIn, or book a quick call.

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.