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.
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.
HUKUIBIO invites you to contact us at [email protected] to discuss your medical device development efforts in China, including regulatory impacts that may impact your intended commercialization strategies.