NMPA Update: New Devices Exempt from Clinical Evaluation

The NMPA has just released an updated list of medical devices that are exempt from clinical evaluation.

In 2023, the list included 1,025 devices. This year, 22 additional devices have been added.

The NMPA updates this exemption list every two years.

Every manufacturer dreams of preparing just one set of technical documents that satisfies all global regulatory bodies.

Unfortunately, that's still far from reality. While many foreign regulators accept clinical evaluation reports from the EU or the U.S., not all do - and China is one of them.

Is your device now exempt from clinical evaluation? Let’s find out.

🍜 List of Devices Exempt from Clinical Evaluation

Here’s a quick look at the 22 medical devices recently added to the exemption list.

The devices are sorted by product category and classification code. The list only consists of Class II and Class III medical devices.

Click here to download the full list directly from NMPA.

The NMPA grants clinical-evaluation exemptions to devices whose design or underlying technology is well-established and has a clearly defined risk profile.

In other words:

• The mechanism of action must be well understood.

• The manufacturing process should be well established.

• Product designs are consistent and robust

• Similar devices must have been on the market for years without serious adverse events.

• The device should not deviate from the stipulated intended use.

Alternatively, you'll need to demonstrate its safety and performance through non-clinical supporting data.

Need a second opinion? Let’s talk.

🍜 What Does It Mean To Your Products?

If you're still in the project planning or document preparation stage, this is great news. Below is a simple flowchart showing the clinical evaluation options:

If your product qualifies for a clinical evaluation exemption, you can save significant time and resources.

In that case, all you need to submit is a Comparison Analysis with a suitable predicate device.

Click here to download the template. It’s free!

However, if you've already submitted your registration dossier, this won’t apply retroactively.

In fact, during the NMPA feedback process, they may now ask you to supply a comparison table instead of a clinical evaluation.

I’ve written more details on the Comparison Analysis in a recent post. Check it out if you're interested.

Need advice or step-by-step guidance on your clinical evaluation strategy? Let’s connect here. Or feel free to reach out via email or LinkedIn.

PS: I currently have capacity to take on a new consultation project.

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. 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.