Regulatory Focus™ > News Articles > SFDA Intends to Regulate Colored Contact Lenses as Medical Devices

SFDA Intends to Regulate Colored Contact Lenses as Medical Devices

Posted 20 January 2012 | By Alexander Gaffney, RAC 

The Chinese State Food and Drug Administration (SFDA) today released a bevy of documents including the fourth national drug quality and medical device quality announcements of 2011, guidance on test methods for hydrocortisone present in cosmetic products, notice of their intent to regulate colored contact lenses as medical devices and strengthen regulations regarding the production and management of clenbuterol.

The notices commented that SFDA had been made aware of the safety risks associated with colored contact lenses in 2011, but that previously it did not meet the definition of a medical device as they were not prescription devices. Regardless, SFDA plans to regulate the devices as Class III medial devices, and will publish regulatory guidance shortly.

SFDA noted that they were looking to "further enhance" compound management for raw materials and aerosols containing clenbuterol through standardized production and management. SFDA is requiring that manufacturers establish customer profiles, verify and retain proof of a purchaser's qualifications, retain copies of personnel identification documents and have someone dedicated to sales and database management.

SFDA also released quality announcements for pharmaceutical products and medical devices, along with testing methods for hydrocortisone and other banned substances in cosmetic products.

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