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 names from the subcategories 01, 04, 07-10, 19 and 21 of the <Category of Medical Devices>. It hence consists of Active Surgical Instruments (01), Orthopedic Surgical Instruments (04), Diagnostic and Monitoring Equipment (07), Anaethetic, Respiratory and Emergency Devices (08), Physical Therapy Devices (09), Blood Transfusion, Dialysis and External Communicating Devices (10), Medical Rehabilitation Devices (19), and Software as Medical Devices (21).

The attached link includes:

1. The instruction for use of the recommended paths for clinical evaluation of products under subcategories 01, 04, 07-10, 19 and 21 of <Category of Medical Devices>.

2. The recommended paths for clinical evaluation of products under subcategory 01 “Active Surgical Instruments”

3. The recommended paths for clinical evaluation of products under subcategory 04 “Orthopedic Surgical Instruments”

4. The recommended paths for clinical evaluation of products under subcategory 07 “Diagnostic and Monitoring Equipment”

5. The recommended paths for clinical evaluation of products under subcategory 08 “Anaethetic, Respiratory and Emergency Devices”

6. The recommended paths for clinical evaluation of products under subcategory 09 “Physical Therapy Devices”

7. The recommended paths for clinical evaluation of products under subcategory 10 “Blood Transfusion, Dialysis and External Communicating Devices”

8. The recommended paths for clinical evaluation of products under subcategory 19 “Medical Rehabilitation Devices”

9. The recommended paths for clinical evaluation of products under subcategory 21 “Software as Medical Devices”

 

 

Reference:
NMPA’s Announcement on Releasing Recommended Paths for Clinical Evaluation of Related Products under Subcategories 01, 04, 07-10, 19, and 21 of the “Category of Medical Devices” (No. 30 of 2022)

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