Optical Prism July 2016 | Page 44

HEALTH CANADA RELEASES NEW DECORATIVE CONTACT LENS REGULATIONS As of July 16, 2016, decorative contact lenses (also known as cosmetic, coloured or fashion contact lenses) will be regulated as Class II medical devices in Canada. In order to sell these lenses, Canadian manufacturers must get a Class II medical device licence. To help your establishment comply with this requirement, Health Canada is pleased to provide you with the following information. Licensing • Decorative contact lenses • Reasons for Health Canada to regulate decorative contact lenses as medical devices • Time for decorative contact lenses to be regulated as medical devices • Classification of decorative contact lenses • Requirement for manufacturers • Information for applying for a medical device licence Compliance and enforcement • Transition period for manufacturers • Requirements for importers and distributors • Health Canada’s role in regulating decorative contact lenses • Approach for Health Canada to respond to a non-compliance DECORATIVE CONTACT LENSES Licensing Decorative contact lenses Decorative contact lenses are used to change the look or colour of a user’s eyes. Unlike corrective contact lenses, they do not correct vision. Decorative contact lenses may also be referred to as cosmetic, coloured or fashion contact lenses. Reasons for Health Canada to regulate decorative contact lenses as medical devices This regulatory change aligns decorative contact lenses with traditional contact lenses, which are already regulated as medical devices. All types of contact lenses have associated risks, including: • cuts or scratches on the top layer of the eyeball (corneal abrasions) • allergic reactions (e.g., itchy, watery, red eyes) • vision impairment • infections • blindness Time for decorative contact lenses to be regulated as medical devices On July 16, 2016, decorative contact lenses will become medical devices. At that time, manufacturers will need to comply with the Medical Devices Regulations (Regulations). For more information about the Regulations, please visit the following link: http://laws-lois.justice. gc.ca/eng/regulations/SOR-98-282/index.html 42 Optical Prism | July 2016