SFDA Places Cosmetic Lens under Control Span of Medical Device

Cosmetic contact lenses shall be registered as the third category of medical device in China from 1st April 2012

China State Food and Drug Administration (SFDA) has issued a notice No 66 of 2012 in February 27 that cosmetic or colored contact lenses on the Chinese market will be placed under the control span of the nation’s third class medical device since next month.

From 1 April 2012, the production/operation license application and the quality control inspections of the cosmetic lens shall apply to relevant standards and regulations on medical contact lenses. Cosmetic lens producers or importers who have not supplied the due registration certificate of Chinese medical device are prohibited to continue with their production, import or sales.

Cosmetic colored contact lens is a type of HEMA-based hydrophilic soft contact lens (SCL) placed on the eye for cosmetic reasons. Main compositions of cosmetic SCL contain hydroxyethylmethacrylate (HEMA)-based mixtures and certain pigments which could cause sensitizing effects to the cornea and iris and lead to other ophthalmic infection if not treated with standard production process such as the full cast moulding system. Popular cosmetic SCL trademarks in domestic China feature Acuvue Define, BESCON, G&G and other Japanese and South Korean brands, yet the market has been flushed with miscellaneous products of varied quality since an adolescent demand for fashion expanded in the past decade.

On 19 January 2012, China SFDA had expressed the agency concern on the current loose management on the cosmetic lens market and the hidden safety risks for consumers. The agency hereafter declared a final decision to include cosmetic SCL into the monitor regime of medical devices and advised producers and distributors that may be short of proper quality control to take early actions to reduce or cease cosmetic SCL production, importation and sales.

Reference Links

• China SFDA Notice 66-2012
• China SFDA press release