On February 12, 2014, the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)" was reviewed and approved by the executive meeting of the State Council and will be promulgated and implemented soon.

　　The current "Regulations on the Supervision and Administration of Medical Devices" was promulgated and implemented in 2000. For more than a decade, with the development and changes of my country's medical device industry, the situation that it is not suitable for new changes in the development of the industry is prominent, and the industry has strong calls for revision. In 2006, the former State Food and Drug Administration started the revision work, organized and carried out dozens of research projects, extensively listened to the opinions of all parties, carefully studied and revised, and submitted the draft to the Legislative Affairs Office of the State Council in March 2008. Subsequently, it actively cooperated with the Legislative Affairs Office of the State Council, repeated research, coordination, demonstration, and revision, and formed the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)."

　　The "Regulations (Revised Draft)" has made a comprehensive amendment to the original "Regulations", with a total of eight chapters and 80 articles. Compared with the eight chapters and 48 articles of the original "Regulations", the main contents of the amendments include: adjustments to the definition and definition of medical devices. Classification rules; further improved product registration, production, operation approval or filing authority; added measures for quality supervision and risk monitoring in the production of medical devices; added medical device adverse event monitoring, traceability, and recall systems; further strengthened Sales link ledger, inspection and acceptance system and certification obligations; new regulations on the supervision of in-use medical devices; increased punishment for illegal acts, etc.

　　The smooth passage of the "Regulations (Revised Draft)" is important for comprehensively advancing administration according to law, improving the legal system for food and drug supervision, ensuring the safety and effectiveness of medical devices, maintaining human health and life safety, and realizing a benign interaction between government governance and social self-regulation significance.