Vol. 149, No. 15 — July 29, 2015
SI/2015-69 July 29, 2015
AN ACT TO AMEND THE FOOD AND DRUGS ACT (NON-CORRECTIVE CONTACT LENSES)
Order Fixing the Day that is 12 months after the Day on which this Order is made as the Day on which the Act Comes into Force
P.C. 2015-1075 July 16, 2015
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 2 of An Act to amend the Food and Drugs Act (non-corrective contact lenses), chapter 25 of the Statutes of Canada, 2012, fixes the day that is 12 months after the day on which this Order is made as the day on which that Act comes into force.
(This note is not part of the Order.)
Pursuant to section 2 of An Act to amend the Food and Drugs Act (non-corrective contact lenses), this Order brings this Act into force 12 months after the day this Order is made. This Act deems non-corrective contact lenses to be medical devices under the Food and Drugs Act.
On December 14, 2012, Private Member’s Bill C-313, An Act to amend the Food and Drugs Act (non-corrective contact lenses), received royal assent. This Act deems non-corrective contact lenses to be medical devices. This Act subjects non-corrective contact lenses to the licensing requirements in the Medical Devices Regulations for the purpose of increasing regulatory oversight of these products and improving consumer safety.
The Governor in Council will make regulations to clarify which regulatory requirements in the Medical Devices Regulations apply to non-corrective decorative contact lenses and to exempt manufacturers of these products from the regulatory requirement to establish therapeutic effectiveness as part of their device licence application because these products have no therapeutic effect. The timing of the coming into force of the Act will be aligned with the registration and coming into force of the legislative amendment.
This legislative amendment ensures the application of similar safety, quality and labelling standards to all contact lenses sold in Canada.
Following the introduction of Bill C-313, numerous eye-care professional stakeholders expressed support for the proposed amendment, citing the health hazards associated with non-corrective lenses and the need for a similar level of regulatory oversight of these products as it currently exists for corrective lenses. One industry stakeholder expressed concern that the regulation of non-corrective lenses could lead to an increase in the retail cost of these products and thus encourage consumers to seek out less expensive, unlicensed non-corrective lenses on the Internet. It is the position of Health Canada that, even if some consumers choose to purchase unlicensed products, the regulation of non-corrective lenses as Class II medical devices will provide a net benefit to the overall health and safety of Canadians.
The Department of Foreign Affairs, Trade and Development (DFATD) was consulted with respect to the potential impact that this proposal may have on barriers to international trade through the Agreement on Technical Barriers to Trade set out under the World Trade Organization. No concerns were raised by DFATD as the 12-month delay in the coming-into-force date of the legislative and regulatory amendments allows foreign manufacturers of non-corrective contact lenses sufficient time to comply with the new requirements. Health Canada will continue to meet its international notification obligations.
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch