In order to guide the registrants to confirm the path for clinical evaluation of specific products, the Center for Medical Device Evaluation (CMDE) in China has announced the recommended paths for clinical evaluation of certain products. That is, which is in accordance with the <Regulation on the Supervision and Administration of Medical Devices>, comply with the requirements in the <Guidance concerning decision of conducting clinical trial of medical devices>, based on the present reviewing experience as well as on the product description, intended purpose, and examples of device name from the subcategories 02, 03, 05, 06, 16, 18 and 20 of the <Category of Medical Devices>. This hence consists of non-active surgical instruments (02), neural and cardiovascular surgical Instruments (03) as well as radiation therapy devices (05), medical imaging devices (06), ophthalmic devices (16), along with obstetric-gynecologic, assisted reproduction and contraceptive devices (18), and Chinese medical devices (20).

The attached link includes:

1. 1. The instruction for use of the recommended paths for clinical evaluation of products under subcategories 02, 03, 05, 06, 16, 18 and 20 of <Category of Medical Devices>.
2. 2. The recommended paths for clinical evaluation of products under subcategory 02 “non-active surgical instruments”
3. 3. The recommended paths for clinical evaluation of products under subcategory 03 “neural and cardiovascular surgical Instruments”
4. 4. The recommended paths for clinical evaluation of products under subcategory 05 “radiation therapy devices”
5. 5. The recommended paths for clinical evaluation of products under subcategory 06 “medical imaging devices”
6. 6. The recommended paths for clinical evaluation of products under subcategory 16 “ophthalmic devices”
7. 7. The recommended paths for clinical evaluation of products under subcategory 18 “obstetric-gynecologic, assisted reproduction and contraceptive devices”
8. 8. The recommended paths for clinical evaluation of products under subcategory 20 “Chinese medical devices”

 

 

Reference:
NMPA’s Announcement on Releasing Recommended Paths for Clinical Evaluation of Related Products under Subcategories 02, 03, 05, 06, 16, 18, and 20  of the “Category of Medical Devices” (No. 24 of 2022)