China medical device clinical evaluation recommended paths were published on May 19, 2022, by the Center for Medical Device Evaluation (CMDE) to help guide registration applicants further in determining the clinical evaluation path of specific products.
The recommended paths specifically refer to products listed in Subdirectories 11, 12, 13, 14, 15, 17 and 22 of the Medical Device Classification Catalogue (No. 20-2022).
These newly published recommended paths for medical device clinical evaluations in China are based on the “Medical Device Supervision Regulations” and in accordance with the “Technical Guidelines for Decision-Making on Whether to Carry Out Clinical Trials of Medical Devices and other normative requirements” (referred to hereafter as the “Decision-Making Guidelines”).
Based on its product review experience, the CMDE is hereby providing recommended opinions on the choice of clinical evaluation paths for specific products according to the product name, product description, and intended use.
The products concerned are found in the following subdirectories of the Medical Device Classification Catalogue:
- medical device disinfection and sterilization devices related products (subdirectory 11)
- active medical devices related products (subdirectory 12)
- passive medical devices related products (subdirectory 13)
- injection, nursing and protective equipment related products (subdirectory 14)
- patient-borne devices related products (subdirectory 15)
- stomatological device-related products (subdirectory 17)
- clinical laboratory devices related products (subdirectory 22)
Please note that those products which have only been submitted for evaluation in small numbers or have not been submitted at all in recent years are not reflected in this newly published guidance.
Products requiring China medical device clinical trials
Products marked as “clinical trials” in the document are usually considered as “high-risk medical devices” in the “Decision-Making Guidelines” and in principle require a clinical trial unless they have been exempted from clinical trials in Part III, paragraph (a) of the Guidelines.
New medical device which have predicate devices
Applicant for products marked as “predicate devices” in the document need to submit clinical trial information if they are considered “new medical devices” unless they are exempted from clinical trials in paragraph (2) of Part III of the “Decision-making Guidelines”. Innovative medical devices as mentioned in the “Decision-Making Guidelines” have significant differences in scope of application, technical characteristics and/or biological characteristics.
Products with predicate devices
Applicants for products marked as “predicate devices” in the document which are not considered “new medical devices” (see above point) can verify the safety and validity of the medical devices by analysing and evaluating the clinical trial data of the predicate device. This is in accordance with the relevant requirements of:
- Technical Guidelines for Clinical Evaluation of Medical Devices
- Technical Guidelines for Clinical Evaluation Reports on The Registration and Declaration of Medical Devices
The predicate device can be selected based on the characteristics of the product, clinical risks as well as clinical data.
However, in cases where the safety and effectiveness of the differential part cannot be proven through non-clinical studies, i.e., the existing evidence cannot prove that the product complies with the basic principles of medical device safety and performance (as stated in the Decision-Making Guidelines), then clinical trial data needs to be submitted.
If you would like to know more about how these recommended paths for clinical evaluation affect your medical device and related products, please contact us.
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By Julie Zhang.