State Drug Administration investigating color contact lenses quality and safety supervision work

On September 2nd, Xu Jinghe, deputy director of the State Drug Administration, led the team to investigate the quality and safety of color contact lenses in Beijing, and held a symposium at the site of Beijing Bocalian Eye Care Products Co., Ltd.

Beijing Bocnata Eye Care Products Co., Ltd., Beijing Weikang Dakang Technology Co., Ltd., Beijing Dommei Electronic Commerce Co., Ltd., and Beijing Yiming Glasses Co., Ltd. reported the quality management of color contact lenses. The Beijing Pharmaceutical Supervision Bureau and the market supervision bureaus of Dongcheng District, Chaoyang District, and Fengtai District made reports on strengthening the quality and safety supervision of color contact lenses.

At the symposium, the research team and the production and operation enterprises and regulatory departments conducted in -depth exchanges and discussions on the problems of color contact lenses and how to further strengthen quality and safety supervision.

The Beijing Municipal Drug Administration attaches great importance to the special rectification operation requirements of the production and operation behavior of standardized decorative color contact lenses, and immediately organizes research and implementation. Management, guide the area market supervision bureaus based on residential areas, bustling neighborhoods, shopping malls, and surrounding schools to strengthen the quality supervision of contact lenses. Focusing on color contact lenses, it is comprehensive monitor.

Xu Jinghe pointed out that color contact lenses are third categories of medical devices with higher risks. According to the "Regulations on the Supervision and Administration of Medical Device", products that are "strictly controlled and managed by special measures". Production enterprises must establish and improve the production quality management system in accordance with laws and regulations, and continue to ensure that the quality of the product is qualified; operating enterprises must ensure that the product sources are legal in accordance with laws and regulations, strictly implement the certificate of certificate and purchase inspection records, especially those engaged in online sales. To ensure that "online and offline consistent", the product information displayed online should be true, accurate, complete, and traceable.

Xu Jinghe emphasized that the special rectification of color contact lenses is an important part of the special rectification operation of drug safety. Drug supervision and management departments at all levels should further improve their political standing, and in accordance with the "Notice of the Comprehensive Department of the State Drug Administration on the Development of the Special Rectification Action for the Development of Devitarous Color Invisible Curses", quickly act Maintain the rights and interests of consumers; we must adhere to the problem orientation, carefully sort out the production and operation links, especially the outstanding problems existing in the online sales link, strictly regulate production and operation activities, and strictly rectify quality and safety violations of laws and regulations. Carefully implement the main responsibility of the enterprise, the regulatory authorities must conscientiously implement the responsibility of territorial regulatory supervision, and comprehensively strengthen the quality management of the entire life cycle of color contact lenses. In accordance with the "four strictest" requirements, we must severely punish various violations of laws and regulations to ensure the safety bottom line. It is necessary to adhere to social co -governance, strengthen product options and use methods, and guide consumers to correctly select and use color contact lenses.

The heads of the Institute of Devices Supervision and relevant personnel of the State Drug Administration participated in the investigation.

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