Product risk isn’t fixed.

China updates its product catalogue regularly, usually at least once every two years.

In January, the NMPA revised the product catalogue.

Soon after that update, the NMPA released a draft list of medical devices that will require clinical trial approval in China.

This week, I’ll break down the common mistakes I see in China market entry planning.

I’ll also cover the new draft and what this could mean for manufacturers.

🍜 Common Mistakes

Many manufacturers don’t plan for China early enough.

Most teams start with the US and EU.

The thinking usually goes like this:

“We’ll design for the US and EU first, then figure out China later.”

This mindset can backfire.

As EU MDR compliance or a 510(k) clearance doesn’t guarantee China registration.

Yes, China asks you to submit evidence of overseas approvals.

But that doesn’t mean the NMPA treats the EU as a reference country or offers an “expedited” path just because you have CE marking.

By the time teams realize the gaps, it’s often too late.

The device may already miss China-specific requirements.

This includes:

Chinese Technical Requirements

Many products are developed without considering China’s local standards.

The technical parameters in ISO and YY standards don’t always match.

China’s acceptance criteria can also be tighter for certain product standards.

A design that passes testing in the EU may fail in China type testing.

Then you’re stuck redesigning or re-engineering for China. This adds cost and months to the timeline.

How to avoid this?

Build country-specific standards and requirements into your plan from day one of product development.

Intended Use

Your intended use statement may be broader than what the China classification catalogue allows for that device code.

In China, your claimed scope should align with the catalogue and stay within it.

If your wording goes beyond the listed scope, you can trigger questions on risk and clinical evidence.

That can push you into a heavier clinical route than you planned for.

How to navigate this?

Align with the product catalogue earlier when defining the intended use.

Clinical Strategy

China has clear lists of devices that are exempt from clinical evaluation and devices that require a clinical trial.

For details, check out my previous post on the clinical evaluation routes in China.

If your product falls into the clinical trial bucket, you need to plan early. Or build China into your global multicenter strategy from the start.

China also has clinical expectations that US or EU doesn’t cover. This includes demographics, ethnicity-related factors, and clinical endpoints.

Some Class II devices are exempt from clinical evaluation, and you should check them early.

If you do need a clinical evaluation based on equivalence, your chosen predicate should be NMPA-approved.

A strong EU predicate won’t help if it isn’t registered in China.

You can’t just translate your EU MDR technical file and submit it to the NMPA.

If you’re stuck mapping your EU MDR dossier to China requirements, let’s talk.

🍜 Draft Catalogue for Class III Devices Requiring Clinical Trial Approval

What’s new this week?

To match the current regulatory landscape, the NMPA proposed adding three more Class III devices to the list that require clinical trial approval in China.

The additions and the product description are:

Implantable Brain-Computer Interface Devices

It’s usually composed of implantable electrodes, implantable signal collectors, decoding software or devices, and external control equipment.

They aim to restore or compensate motor function in patients with central nervous system damage.

They may also support vision or hearing restoration or enhancement.

Implantable Atrial Shunt Devices

These devices typically use a rivet-free double-disc internal clamping structure woven from nickel-titanium alloy wire.

They are implanted through the femoral vein into the cardiac interatrial septum.

It diverts atrial blood and reduces pressure through a shunt opening.

It’s used for maintenance therapy of interatrial septal fistulas in heart failure caused by various etiologies.

Central Nervous System Injury Repair Devices

Primarily composed of collagen and similar materials.

It provides a repair pathway and environment for central nervous system injuries.

Before this draft, six devices across ophthalmology, dentistry, and active and non-active implants were already in the scope.

That includes:

• Implantable Cardiac Pacing Devices

• Implantable Ventricular Assist Systems

• Implantable Drug Delivery Devices

• Artificial Heart Valves and Intravascular Stents

• Tissue Engineering Medical Products Containing Living Cells

• Absorbable Long Bone Internal Fixation Implants

The draft list would include nine device types in total that require clinical trial approval in China.

🍜 The Impact

These Class III devices carry a higher risk to patients than products already on the market, whether in China or overseas.

Before initiating a clinical trial, you must get Ethics Committee (EC) approval and complete the required filing in the Clinical Trial Institution Filing System.

If your Class III device is on this list, you also need NMPA clinical trial approval. This is separate from EC approval.

It usually takes another three to four months.

But it can easily take longer if the NMPA comes back with questions or asks you to revise the protocol or strengthen your risk justification.

This requirement also applies to multicenter trials that include China sites.

Additionally, if your global trial involves exporting China-origin human samples or related data, you may also need apply for China’s human genetic resources (HGR) approval.

If China is part of your clinical plan, you need to consider these steps and timelines in your trial strategy from the start.

🍜 Why Medtech Chopsticks?

If this post made you pause and think, you’re not overthinking it.

China isn’t like any other country.

If you’re running into issues with registration, standards, intended use, or clinical strategy for China, book an intro call here.

This is for startups and small to mid-sized manufacturers.

We’ll look at what’s most likely to slow you down in China, and what to fix before you spend months on the wrong plan.

Stay compliant. Move efficiently.

If this issue was useful, subscribe to Medtech Chopsticks.

Join other RA/QA specialists to stay informed about China’s ever-changing medtech regulations.

Forwarded this email? Sign up here
Follow me on 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. 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.