Health Canada is amending the Medical Devices Regulations for non-corrective or ‘cosmetic’ contact lenses to fall under Class II medical devices.
Cosmetic contact lenses (also called decorative lenses) are used to change the colour or appearance of the eyes. These types of lenses have been regulated as consumer products. However the risks of decorative lenses are identical to the risks of corrective lenses and adverse events causing harm and even permanent damage to the eyes are not uncommon.
These amendments introduce two sets of changes to the Regulations, both involving the licence application requirements for Class II medical devices.
The first amendment addresses the absence of therapeutic effect in non-corrective contact lenses. With their being deemed as devices under the Food and Drugs Act, non-corrective contact lenses will be subject to all of the licensing requirements for Class II devices under the Regulations. However, an exemption is made so that manufacturers of non-corrective contact lenses will not be required to demonstrate therapeutic effectiveness for these products. The amendments to the Regulations to exempt non-corrective contact lens and to the Food and Drugs Act will come into force at the same time.
The second amendment to the Regulations will require manufacturers of all Class II devices to submit a copy of the product label as part of the Class II medical device licence application.
The proposed amendment to the Medical Devices Regulations relating to non-corrective contact lenses will come into effect July 16, 2016.
As medical devices, cosmetic contact lenses will be subject to specific requirements for licensing, manufacturing, labeling, and instructions to improve their safety before they go on the market.
The proposed amendments require labelling for decorative contact lenses, and a requirement to submit a copy of the device label with all Class II device licence application forms.
The medical-device safety standards for non-corrective or ‘cosmetic’ contact lenses as prescription or corrective contact lenses proposed amendment is available in the Canada Gazette II Vol.149 No. 15.