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 roughly equivalent to the entire population of Slovenia. Imagine every Slovene submitting a report - it's an enormous number!

In China, however, the National Medical Products Administration (NMPA) received only > 780,000 adverse event reports in 2023. Why such a big difference?

Some companies neglect their reporting responsibilities. Additionally, limited regulatory enforcement further exacerbates this gap.

To address this issue, the NMPA enforced stricter post-market surveillance (PMS) requirements, urging registration holders to engage proactively.

Re-evaluation of medical devices already on the market is now mandatory.

Are you ready to explore China's medical device reassessment requirements?

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?

Reassessing of medical device means continuously checking its safety and effectiveness and swiftly addressing any new risks that pop up along the way.

Typically, you’ll need to reassess your device under these three scenarios:

1. When science and technology develop

New developments and discoveries can change the state-of-the-art or current understanding of medical device safety and effectiveness.

2. When you identify potential defects through adverse events

The review of adverse events can reveal potential defects or unexpected risks. It's time to reevaluate if those risks could outweigh the device’s benefits.

3. When NMPA rings your bell

Sometimes, the NMPA directly calls for reassessment, particularly if there's a spike in adverse events tied to similar products already on the market.

Always stay ahead by regularly checking what's new in your industry and investing proactively in risk management.

It’s not just about compliance. These are smart risk measures save you from headaches and unnecessary costs in the long run.

🍜 What Are The Requirements?

When reassessing your medical device, you must collect comprehensive post-market data covering clinical performance, safety and effectiveness, usability, and information from reliable sources.

Depending on the findings, you may need to revisit your technical documentation, research data, clinical evaluation, risk assessment, product technical requirements (PTR), instructions for use, and labeling.

Your re-evaluation report should include risk-benefit analysis, socio-economic impacts, state-of-the-art technology, and relevant risk control measures.

If your reassessment reveals significant safety concerns or product defects, you must implement effective risk-control measures to lower risks to an acceptable level.

You should voluntarily withdraw your medical device registration if risks cannot be effectively managed.

The NMPA retains the authority to revoke registrations or phase out previously approved products if they determine your risk controls aren't sufficient or if continued device use could harm patients.

In such cases, manufacturers must immediately halt production, sales, and distribution activities. A recall is needed in the worst case.

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

Having concerns about your reassessment? Reach out to me before it is too late.

🍜 What Is The Reporting Timeline?

Medical device reassessment can 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 re-evaluation plan at least 30 calendar days before starting the reassessment.

Once your reassessment is completed, the final report must be submitted within 30 calendar days.

You must inform NMPA of the status in the form of an annual report if your reassessment extends beyond one year.

When the NMPA initiates a reassessment, it's likely due to specific concerns identified by the monitoring agency. Stay proactive and prepared!

🍜 How Do You 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 access, report, and retrieve adverse events.

As a foreign registration holder, your submission relies entirely on your local representative.

The foreign registration holder is highly dependent on the local representative. Therefore, selecting a trustworthy and knowledgeable representative is critical.

Still have questions? Schedule a call here, or feel free to reach out via email or LinkedIn.

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.