Food and Drug Administration: Strengthening supervision of decorative colored plain contact lenses

According to the State Food and Drug Administration website, a few days ago, the State Food and Drug Administration issued a notice on the supervision of decorative colored plain contact lenses. The notice is clear, in the future, registration applications for decorative colored plain contact lenses will be accepted in accordance with the third category of medical devices.

The notice pointed out that the production licenses, business licenses, quality management system inspections and daily supervision of such products should be conducted in accordance with relevant standards and regulations for contact lenses. As of April 1, 2012, no such product has been registered for a medical device, and the corresponding certificate of production and operation has not been produced or operated. Violation of the relevant provisions of the supervision and management of medical devices, production and operation of such products, shall be strictly investigated and dealt with in accordance with the "Regulations on Medical Device Supervision and Management" and other relevant regulations.

The notification requires that the food and drug regulatory authorities of all provinces (autonomous regions and municipalities) should attach great importance to the supervision of decorative colored plain contact lenses, combine the market conditions of such products in the administrative region, strengthen publicity and guidance, and carry out targeted special rectification work to ensure that The development, production, operation, and use of such products comply with the relevant regulations for the supervision and management of medical devices.