Recently, the State Food and Drug Administration issued the "Notice on Carrying out the Special Rectification of Medical Device Quality and Safety in 2023" (hereinafter referred to as the "Notice"), deploying to carry out the special rectification of medical device quality and safety in 2023.

According to the "Notice", this special rectification focuses on potential safety risks, strengthens the supervision of key products, compacts the main responsibilities of enterprises, improves the regulatory work mechanism, and strives to effectively improve the quality management level of enterprises, effectively improve regulatory efficiency, continuously optimize the market environment, and continuously optimize the regulatory system and mechanism to ensure product quality and safety.

The Notice requires drug regulatory authorities at all levels to continuously strengthen the supervision and management of key products such as medical devices for epidemic prevention and control, key enterprises such as the commissioned production of medical device registrants, key links such as online sales, and key areas such as the use of medical beauty, improve operational mechanisms, enhance regulatory capabilities, strictly investigate violations, and strictly control safety risks. At the same time, the Notice proposes seven working measures: adhering to the principle of assigning responsibilities to individuals, promoting risk consultation, strengthening system inspection, focusing on improving quality and efficiency, promoting typical guidance, implementing severe punishment and punishment, and strengthening assessment and evaluation.

The Notice emphasizes that in the special rectification work, drug regulatory departments at all levels should improve their political standing and strengthen organizational leadership; Strengthen capacity building and improve regulatory level; Strengthen social co governance and improve action effectiveness; Increase publicity efforts and create a good atmosphere.