In China, medical devices are categorized into three regulatory classes based on the degree of risk level.
Class Ⅰ includes medical devices with the lowest risk, where safety and effectiveness can be ensured through routine administration. Only filing is required.
Class Ⅱ includes medical devices with moderate risk, where strict control and administration are required to ensure their safety and effectiveness. Registration is required.
Class Ⅲ includes medical devices with the highest risk and must be strictly controlled and administered through special measures in respect to safety and effectiveness. Registration is required.
2. Methods for Determining the Classification
1. Search Online
Visit the NMPA’s website and go to the “医疗器械分类目录 (Classification Catalogue of Medical Devices)” search page.
2. Query Classification Rules/Catalogue
Directly query Rules for the Classification of Medical Devices or download Classification Catalogue of Medical Devices.
3. Submit a Request for Classification
For devices made in China, you should submit the classification request to local Provincial Bureau; for imports, please submit the request to Center for Standardized Supervision.
4. Submit Directly to the NMPA as Class III Products
Medical device which is not listed in Classification Catalogue may be submitted to the NMPA for registration as a Class Ⅲ device, and then CMDE will assign the device into one of three regulatory classes.
5. Innovative, Prior, and Drug-Device Combination Products
Those belonging to innovative, prior, and drug-device combination products, when entering corresponding process, can be immediately assigned to product classification.
