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.
|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|
|(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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