1, a class of products are low-risk medical devices, usually used for routine medical diagnosis, treatment and care, such as some common thermometer, masks, infusion sets, etc.. The safety of these products is more words, do not need to go through clinical trials, the registration process is relatively simplified.
2, Class II products are medium-risk medical devices, usually used to assist medical diagnosis and treatment, such as X-ray machines, electrocardiographs, blood wave dialysis equipment. These products are higher risk and need to undergo clinical trials and safety evaluations, and the registration process is relatively complex.
3, Class III products are high-risk medical devices, usually used in the diagnosis and treatment of major diseases, such as pacemakers, artificial joints, artificial heart. These products are high risk and need to go through strict clinical trials, safety evaluation and efficacy evaluation, and the registration process is relatively complicated. According to China's "Regulations for the Supervision and Administration of Medical Devices", different categories of medical devices have different requirements and approval procedures for registration, manufacturing, sales and use, etc. Specific details and requirements may be adjusted based on *new* regulations and policies, so consult with the China National Drug Administration (NMPA) or relevant authorities for accurate and new information in specific cases.