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