Bryan Gilburg - China

“Having a product on the clinical trial exemption list can be critical to your business strategy in China. This year, 11 devices are being considered for addition to the list.”

Bryan Gilburg

Managing Director

Come grow with us in the US in Thailand in China in Korea in the Philippines in Taiwan in Hong Kong

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China Releases Draft Clinical Evaluation Exemption List for 2022

Published on: July 15th, 2022

On July 5, 2022, the NMPA’s Center for Medical Device Evaluation (CMDE) has released their annual draft of Clinical Evaluation Exemption List. In this version, 11 medical devices, as listed below, are being considered to be included in the Exemption Catalogue and are open for comment.

Since its inception, the Clinical Trial Exemption List has been an important factor for foreign manufacturers considering entering the Chinese market as the Clinical Trials can be redundant, costly and time consuming. For a product type to be added to the Exemption List, the NMPA must see the device’s technology as mature with a proven history of safety and effectiveness or find that clinical trials with this type of product are not feasible.

Products Being Considered for Clinical Evaluation Exemption List

No. Classification Code Product Name Class
1 03-10-01 Single-Use of Intracranial Retractor Fixation Catheter III
2 07-04-02 Neural Monitoring Endotracheal Intubation III
3 08-07-01 Medical air compressors II
4 10-05-04 Negative pressure assisted venous drainage controllers III
5 13-06-01 Single/multi-component precast cranioplasty plates and fasteners III
6 14-06-06 Negative pressure drainage sealing membranes II
7 14-13-02 Surgical membranes III
(drug-device combination products)
8 14-15-03 Electric Aspirators for Nasal Secretions II
9 14-15-03 Nasal hemostatic catheters II
10 16-06-02 Contact lens care products III
11 17-05-07 Temporary dental filling materials II

Comments will need to be submitted through email and feedback forms for medical devices and IVDs are available here.

Come Grow With Us

Please contact us if you’d like support understanding these new requirements or are interested in determining whether your product is on the Clinical Evaluation Exemption List in China. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.

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