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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
7	14-13-02	Surgical membranes	(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.

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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.