To further guide registration applicants in determining the clinical evaluation paths for specific products, the Center for Medical Device Evaluation (CMDE) has issued a new notice. This notice is based on the latest product development and application status, scientific research in clinical evaluation, technical practices, and three previous notices, including Notice No. 20 of 2022, No. 24 of 2022, and No. 30 of 2022, which outlined recommended clinical evaluation paths.

The products involved are Class II or Class III medical devices which require clinical trials or same product category comparisons. For example, the recommended clinical evaluation path for knuckle prostheses is same product category comparisons.

For further information, please find the appendices: 

1. Instructions for Use of Recommended Pathway for Clinical Evaluation of Products Related to the Classification Catalog of Medical Devices (Supplement in 2024) 
2. Recommended Pathway for Clinical Evaluation of Products Related to the Classification Catalog of Medical Devices (Supplement in 2024)

 

 

References:

Notice of the CMDE on the Publication of Recommended Pathways for Clinical Evaluation of Products Related to the Classification Catalogue of Medical Devices (Supplement in 2024) (No. 11 of 2024)