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 11-15, 17, and 22 of the <Category of Medical Devices>. This hence consists of disinfected and sterilized devices (11), certain active as well as non-active devices (12 and 13), infusion, recovery and protective devices (14), patient carrying devices (15), along with dental devices (17), and clinical investigational and testing devices (22).

The attached link includes:

  1. 1. The instruction for use of recommended paths for clinical evaluation of products under subcategories 11-15, 17, and 22 of <Category of Medical Devices>.
  2. 2. The recommended paths for clinical evaluation of products under subcategory 11 “Disinfected and Sterilized Devices”
  3. 3. The recommended paths for clinical evaluation of products under subcategory 12 “Active Devices”
  4. 4. The recommended paths for clinical evaluation of products under subcategory 13 “Non-Active Devices”
  5. 5. The recommended paths for clinical evaluation of products under subcategory 14 “Infusion, recovery and protective Devices”
  6. 6. The recommended paths for clinical evaluation of products under subcategory 15 “Patient Carrying Devices”
  7. 7. The recommended paths for clinical evaluation of products under subcategory 17 “Dental Devices”
  8. 8. The recommended paths for clinical evaluation of products under subcategory 22 “Clinical Investigational and Testing Devices”

 

 

Reference:
Announcement of NMPA on releasing of Recommended Paths for Clinical Evaluation of Related Products under subcategories 11-15, 17, and 22 of <Category of Medical Devices> (No. 20 of 2022)

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