SFDA Certification

SFDA is the abbreviation of the State Food and Drug Administration of the People’s Republic of China. In order to standardize the

registration and management of medical device products and ensure the safety and effectiveness of medical devices, the State Food

and Drug Administration has formulated the Medical Device Registration Management Measures in accordance with the “Medical

Device Supervision and Management Regulations”.

Measures require

Medical device products sold and used in China should be registered in accordance with the provisions of these measures.

Medical devices that have not been approved for registration shall not be sold or used. Medical device registration refers to the

process of systematically evaluating the safety and effectiveness of medical devices to be marketed and used in accordance with legal

procedures to decide whether to agree to their sale and use. It is divided into domestic medical device registration and overseas

medical device registration. Overseas medical devices, whether they are Class I, Class II, or Class III, must be handled by the Beijing

State Food and Drug Administration: Class I and Class II medical devices in China are handled by the local provincial or municipal food

and drug supervision bureau, and Class III medical devices are handled by the State Food and Drug Administration. The medical device

registration certificate refers to the legal identity card of medical machinery products.