Clinical Evaluation Routes for Medical Devices in China

Time to market is critical. This is especially true if you have fierce competitors who are developing similar solutions to fill market needs.

Therefore, choosing the right clinical route becomes a strategy that can save you time. Similarly, insisting on an “expedited” pathway with insufficient data is also a path to failure.

3 Surviving Clinical Routes for Medical Devices in China

Clinical evaluation-waived pathway
Medical devices that are exempted from clinical trials and clinical evaluation (refer to this post if you belong to this lucky herd)

Equivalence pathway
These are for medical devices that are not exempted from clinical evaluation. You need to justify that your product is identical to the device that has been approved by NMPA. There are two approaches to conducting clinical evaluation:

1. Using the clinical data of equivalent medical devices
2. Using the clinical data from comparable medical devices

Clinical trial pathway
Medical devices that encompass novel technologies or those that do not have sufficient evidence on their safety and effectiveness. This won’t be further elaborated in this post.

What criteria does my product need to match to be considered substantially equivalent?

For Option 2, sufficient scientific evidence and justification must be presented to prove that your product and the approved device achieve similar levels of technical and biological aspects despite of differences. The differences shall not affect the safety and clinical performance of your product compared to the equivalent device of your choice.

What if there isn’t any approved equivalent device?

Luckily, it is not a dead-end. In this case, NMPA may also accept that if your product is similar to a comparable device or devices. The comparison criteria are the same as with the equivalence route.

Although similarities are present in your product and the comparable device, similarities and differences in intended use, technical and biological aspects must be clearly explained.

You can use the clinical trial data of the comparable device as a part of supporting evidence. The role of the clinical data (e.g. safety) must be explained, and a justification must be provided for such claims based on the similarities and differences.

Source of Clinical Evaluation Data

Regardless of whether you opt for equivalence or comparable pathways, the source of clinical evaluation can come from:

Clinical literature data
This comprises published clinical trial or adverse event reports, etc., which are relevant to your device. The collected data is not limited to the clinical data of the equivalent device but also other devices which has not been approved by NMPA.

Clinical experience data
Non-clinical data which involves the information relevant to the clinical use of your product or equivalent device. This form of data can be a post-market surveillance report, or patient history data, adverse event database report and recall data, etc.

Clinical trial originated data
The applicant who conducts a clinical trial can incorporate the approval from ethics committee, implementation and clinical trial results into the clinical evaluation. This applies to all single-center or multi-center clinical trials within China or outside China.

The last two ingredients you are still missing are a beautiful template and the comparison content. As I can’t advise on the content without knowing your imaginary product, how about first taking a glimpse at the template?

Just shoot an email to [email protected] with the subject line “I want my clinical evaluation nuggets” and the free copy will be on its way!

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Disclaimer: This content is created solely in my personal interest and do 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 is non-commercial and 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.