Can a medical device be exempt from Clinical Evaluation?

What do you need to fulfill the clinical requirements of the medical devices in China? It is assumed that you already know the prerequisites of your medical devices - the intended use, risk class, technical, biological aspects, as well as the product classification code of your products.

Ask yourself these three questions to define the clinical strategy for your products in China:

• Does my product require a local clinical trial?

• Is my product covered within the scope of the clinical evaluation exemption?

• What are the options if my product is not exempted from clinical trial or clinical evaluation?

My previous post elaborated on the criteria the product must fulfill to be clinically exempt. For this post, I will cover the eligibility assessment of the clinical evaluation exemption.

Is my product exempt from clinical evaluation?

The National Medical Products Administration (NMPA) published “Guidance on the Product Comparison Analysis for the Medical Device covered under the Catalogue of Clinical Evaluation Exemption” according to Announcement No. 73 of 2021.

Using the identification of the Chinese product classification code, you can check whether your product is listed in the List of medical devices exempted from clinical evaluation (Oops, only in Chinese for now).

This list covers Class II and Class III medical devices, as the filing of Class I medical devices does not require the submission of clinical data. The list was last published in 2023, and it is updated bi-annually. The next update should be blowing over by the end of the year!

What now? My product is exempt from clinical evaluation.

Congratulations! You just dodged one of the massive stumbling blocks, and you are eligible for a simpler version of the clinical evaluation. A comparison assessment to compare your product to the identical or similar products that have acquired marketing approval in China. The supporting documents shall be supplemented together with the assessment table.

Click here to download the comparison template in English for your analysis. The following criteria must be taken into account for the assessment:

• Have identical or similar medical devices been approved in China? It does not matter whether the product has been registered by domestic or foreign manufacturers. Keep searching! The medical device can be used as a predicate as long as it can be found in the NMPA database.

• What are the differences between your product and the chosen predicate(s) in terms of the safety and efficiency of the product? You can use multiple medical devices for comparison if one doesn’t cover all the aspects.

• The comparison criteria include but are not limited to the following:

  1. Working principle/ mechanism of action

  2. Structural composition

  3. Materials used and/or materials in contact with human

  4. Performance requirements

  5. Sterilization or disinfection methods

  6. Intended use

  7. Method of operation

  8. Other relevant criteria based on product type and characteristics

❗Note: Your product must not introduce risks or issues that were absent in the predicate product, especially those that may lead to significant risks and/or problems that highly affect the effectiveness.

The principle from Hippocratic Oath reminds us…

The submitted comparison data should demonstrate that your product and the predicate product listed in the Product List are equivalent. If your product is not fundamentally equivalent to the product described in the Product List, a clinical evaluation shall be performed instead.

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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 general informational purposes only 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.