China medical device clinical evaluation pathways for certain products listed in the China Medical Device Classification Catalogue have been updated by the National Medical Products Administration (NMPA). The updates include product descriptions, intended use, and examples of product names across the 22 subdirectories of the Medical Device Classification Catalogue. The recommended clinical evaluation pathways were outlined in three announcements:
- one for subdirectories 11, 12, 13, 14, 15, 17, and 22;
- another for subdirectories 02, 03, 05, 06, 16, 18, and 20;
- and the third for subdirectories 01, 04, 07, 08, 09, 10, 19, and 21.
Thanks to advancements in product research and registration application submissions, as well as scientific research outcomes in clinical evaluation and technical review practices, clearer clinical evaluation pathways have been outlined for certain products. Notably, these include:
- surgical navigation systems
- ex vivo organ perfusion transportation devices
- implantable wires for plastic surgery amongst others.
How to determine what kind of clinical evaluation is required
There are two possible pathways for clinical evaluation:
- Clinical evaluation via overseas or domestic (China) clinical trial data
- Clinical evaluation via comparison with same product type a.k.a predicate devices already registered on the market.
Products labeled with “clinical trials” in the Classification Catalogue are generally considered “high-risk medical devices” as per the “Guiding Principles for Decision-making on Clinical Trials of Medical Devices” (referred to as the “Guiding Principles”). Clinical trials are typically required unless specified in part (3), section (1) of the Guiding Principles where exemptions from clinical trials may be considered. Products labeled as “same type” or “same type comparison” that differ significantly in scope of application, technical features, and/or biological characteristics compared to other devices of the same type are considered “new medical devices” as per the Guiding Principles. Clinical trial data (domestic or overseas) must be submitted for these products unless specified in part (3), section (2) of the Guiding Principles. Manufacturers of products labeled as “same type” that are not considered “new medical devices,” can choose suitable devices of the same variety and conduct analysis and evaluation based on clinical data of these predicate devices. This process must demonstrate the safety and efficacy of the differing parts of the medical device through comparative non-clinical studies. However, failure to do so means that the product’s evidence cannot prove compliance with basic principles of medical device safety and performance and such products will therefore be required to undertake a clinical trial.
Examples of clinical evaluation pathways for medical devices
Here are some examples of recently added recommended clinical evaluation pathways for medical devices listed in the Classification Catalogue:
Further information:
Read the original China medical device clinical evaluation.
Discover the list of medical devices exempted from clinical evaluation in 2023.
Discover Cisema’s services in supporting medical devices entering the China market identifying the optimal pathway.