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Decorative Contact Lenses now regulated as Class II medical device with Health Canada

Tuesday, July 26, 2016

On July 16, 2016, Health Canada announced that decorative contact lenses (also known as cosmetic, coloured or fashion contact lenses) will be regulated as Class II medical devices in Canada.  This means that all manufacturers of decorative contact lenses will now need to obtain a Class II medical devices licence before they can sell this type of contact lens in Canada.  However, manufacturers will be given a 12-month transition period to obtain this licence. To learn more about this regulatory change, please click HERE.

Optometrists and opticians are advised against buying or selling any unlicensed decorative contact lenses after July 16, 2017.  Because Health Canada has not assessed their safety and effectiveness, their use may pose a risk to a patient’s health and safety.

Health Canada is further advising that if optometrists or patients themselves experience a problem relating to the failure, defect or inadequate instruction of a licensed or unlicensed medical device such as decorative contact lenses, they are encouraged to report it to both the device manufacturer and Health Canada.  For more information about making a complaint about a health product, please click HERE.

Exigences réglementaires relatives aux lentilles cornéennes à but esthétiques

La présente a pour objet de vous informer qu’à compter du 16 juillet 2016, les lentilles cornéennes à but esthétiques (aussi appelées lentilles cornéennes de couleur, lentilles cornéennes non correctrices) seront réglementées à titre d’instruments médicaux de classe II au Canada.  Tous les fabricants de lentilles cornéennes à but esthétique devront obtenir une homologation pour instrument médical de classe II avant de vendre ce type de lentille cornéenne au…