RA talks a lot about regulatory strategy.

But if you listen closely, many of those discussions actually revolve around clinical claims.

Intended use. Indications. Patient populations. General safety and performance requirements.

All of this sits in the clinical bucket.

You need clinical evidence to show that your device meets the relevant safety and performance requirements.

And you need evidence that aligns with your device’s characteristics and intended purpose.

Both China and the EU accept clinical evaluations.

But the structure and regulatory framework are not the same.

In this series, I’ll walk through the clinical evaluation pathways in China and how they differ from the EU MDR.

🍜 Clinical Evaluation Routes in China

China actually has clearer clinical pathways for medical devices than the EU does.

In practice, you are looking at three main routes:

🍜 Clinical Evaluation-exempt Pathway

This applies to devices that are exempt from both clinical trials and clinical evaluation in China.

A device may qualify for exemption if:

• The working mechanism is clear, design is finalized, production process is mature, same type of device has been used clinically for many years in China without serious adverse events, and its routine use has not changed.

• Non-clinical data alone are sufficient to demonstrate safety and effectiveness.

However, not every device that meets these points is exempt.

You only benefit from this route if your product category appears on the official List of Medical Devices Exempt from Clinical Evaluation.

If it is on the list, the requirement is relatively light.

You mainly need to compile a straightforward comparison table to show that your product really matches the listed device.

The EU MDR and MDCG guidance do not offer this kind of exemption list.

I covered how to assess whether your device falls into this group in a previous issue.

It is worth going back to it if you missed that.

🍜 Equivalence Pathway

If your device is not exempt, the next option is to go down the equivalence route.

This route is widely used in China.

Here, you need to justify that your product is identical or comparable to a device already approved by the NMPA.

There are two ways to build your clinical evaluation on equivalence:

• Use clinical data from equivalent medical devices

• Use clinical data from comparable medical devices

Your device is considered substantially equivalent if the intended use, and the technical and biological characteristics are the same.

Even if there are differences, both devices achieve a similar technical and biological performance.

For a comparable device, you need enough scientific evidence and justifications.

The differences must not change the safety profile or the clinical performance of your product compared with the chosen predicate.

You also need to run a literature search in Chinese databases and include the relevant publications in your clinical evaluation.

This is not optional. NMPA expects to see local literature.

But under MDR, it has become much harder to apply in practice if you do not own the equivalent device.

🍜 Clinical Trial Pathway

If there is no equivalent or comparable device, you are likely heading into a local clinical trial in China.

This is usually the case for:

• Devices with novel or innovative technology

• Devices without a suitable predicate

• Situations where existing clinical data cannot sufficiently demonstrate safety and effectiveness

You choose this route if your overseas clinical data does not meet the NMPA’s acceptance criteria.

Or it yields different clinical outcomes across population groups.

I recently appeared as a guest on the recent Global Medical Device Podcast, moderated by Etienne Nichols from Greenlight Guru.

I discussed what “ethnological differences” mean and how you can collect local pre-market clinical data in China.

If you want to go deeper into the exemption angle, you can go back to my earlier issue. I broke down the criteria for clinical-exempt in more detail.

🍜 Key Differences between the EU and China

Beyond the fact that equivalence is harder to use under the EU MDR, two systems don’t share the same mindset when it comes to clinical evaluation.

 🍜 Product Lifecycle

Under MDR, clinical evaluation is not a one-off exercise after your initial CE mark.

The MDR, together with MDCG 2020-6, 2020-13 and 2021-6, raises the bar for clinical evidence, especially for implantable and Class III devices.

The EU framework expects clinical evaluation to be a continuous lifecycle process.

It expects you to interlink post-market surveillance (PMS) and post-market clinical follow-up (PMCF) into the clinical evaluation report.

The CER is not static.

It should evolve as new safety and performance data come in.

Even if your technology is well established, Notified Bodies still expect PMCF activities or new clinical investigations to show ongoing safety and performance under MDR.

PMCF is not explicitly defined in China.

However, you still need to update the clinical evaluation periodically, as new information on product safety, clinical performance and effectiveness becomes available.

At the same time, manufacturers must follow China’s separate PMS requirements.

🍜 Clinical Trials

Under MDR, implantable and Class III devices generally need clinical investigations.

You only get out of that if:

• Your device is a modification of one you already market, and you can clearly demonstrate equivalence, or

• You already have sufficient clinical data and PMCF from the existing device

All medical devices placed on the EU market need a clinical evaluation.

China doesn’t follow the same logic.

Not all Class III medical devices in China require clinical trials.

Class II and Class III devices can skip clinical investigations if they fall under the Catalogue of Medical Devices Exempt from Clinical Trials.

For Class I medical devices, you don’t need clinical evidence for the product approval filing.

You can avoid running a clinical study if you can establish equivalence with domestic predicates in China.

Let’s chat if you need support in mapping your clinical strategy.

🍜 Equivalence-based Clinical Evaluation

Under MDR, the rules on equivalence make it very hard to acquire competitor data.

According to Article 61 of the EU MDR, you need a contract with that manufacturer if you want to rely on an equivalent device that you do not manufacture.

That contract must give you ongoing full access to their technical documentation.

What? No competitor will ever agree to that!

On top of that, Notified Bodies frequently challenge equivalence claims.

They ask for detailed justification and often push back if they see gaps.

As for China, NMPA actually expects you to reference a local same-type predicate.

You need to identify a China-approved predicate device, which is often not the one you used in your EU CER.

That China-specific predicate then becomes the anchor for your equivalence-based clinical evaluation.

🍜 Content Requirements

MDR, MDCG 2020-6, 2020-13, 2021-6, MEDDEV 2.7/1 Rev. 4, and related guidances shape the structure and expectations for clinical evaluation in the EU.

A typical MDR-compliant CER covers like:

• Device description and intended purpose

• Clinical background and claims, taking into account the state of the art

• Regulatory and market history

• Existing treatment options and clinical practice

• Literature search and review methods

• Clinical data (pre-market and post-market, including comparable devices)

• Benefit-risk analysis and overall conclusions

• Etc.

As explained, EU emphasises the traceability between clinical evaluation, risk management, PMS and PMCF.

You are also expected to update the CER whenever there are design changes, IFU or label changes, new risk mitigations, or when you generate additional PMCF or new clinical investigation data.

The content requirements for EU and China clinical evaluations look quite similar.

But a few points are different and important for China:

• The clinical evaluation scope and route depend on the product’s category in the NMPA catalogues.

• You must compare your device against predicates that are already registered with the NMPA, not just any global comparator.

• You shall include Chinese clinical data or Chinese literature to support safety, clinical performance and effectiveness.

• The CER must be in Chinese and align with the NMPA document structure and local standards where relevant.

So you cannot simply translate your MDR CER into Chinese and attach it.

🍜 Legacy Devices

If you still have MDD-compliant devices under MDR transition, you need to treat them as “legacy devices” and be very clear about what that means for clinical evidence.

For each claimed indication, you have to:

• Identify relevant legacy devices

• Justify the level of clinical evidence that supports conformity with the GSPRs

• Explain why you can still rely on your MDD-era clinical data

• Decide if you need new MDR-era investigations or PMCF, based on MDCG 2020-6

China does not make this distinction.

NMPA does not care whether your device started life under MDD, AIMD or MDR in Europe.

There is no “legacy” category in the same sense.

This whole concept only exists for EU devices moving from MDD to MDR.

Is your current EU MDR clinical evaluation actually enough for China?

If you need help assessing your market entry strategy or checking whether your clinical evidence holds up for NMPA, let’s talk.

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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. 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.