“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
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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