Class III registration of medical devices in China is mandatory, and all products that meet the Class III classification of medical devices must be registered and obtain the corresponding registration certificate before they can be sold and used in China.
Medical devices are special products related to public health and safety, and in order to protect the rights and interests of patients and medical workers, China's National Medical Products Administration (formerly CFDA, now National Medical Products Administration) has implemented a strict regulatory system. The Regulations on the Supervision and Administration of Medical Devices clearly stipulate the registration of medical devices, which stipulates the classification and registration management system of medical devices. Medical devices are divided into three categories according to their degree of risk, and the registration of medical devices in Class III is for products in this category.
According to relevant regulations, the process of Class III registration of medical devices involves the review of product technical evaluation, clinical trial data, production process, quality management system, etc. Only products that have passed the review of the State Food and Drug Administration and issued a registration certificate can legally enter the market for sale and use. Medical devices without a registration certificate are not allowed to be sold and used in China, and violators will face corresponding legal liabilities and penalties.
The mandatory registration of Class III medical devices reflects the strict supervision of the medical device market by the state, aiming to ensure the quality, safety and effectiveness of medical devices. Through the registration management system, the state can effectively monitor the quality and safety of medical devices, prevent low-quality, counterfeit and shoddy products from entering the market, and protect the legitimate rights and interests of patients and medical workers.
Therefore, the Class III registration of medical devices in China is mandatory, and all products that meet the Class III classification of medical devices must be registered, otherwise they will not be able to legally sell and use in the Chinese market.