Sunday, October 19, 2014

Health Canada to Upgrade Cosmetic CLs to Medical Devices

In a press release appearing on, Canada’s Health Minister Rona Ambrose said that Health Canada will consult with optical industry experts to regulate cosmetic contact lenses as medical devices. Until now, Canada has regulated them as consumer products. The U.S. FDA considers them as medical devices, which can be dispensed only with a prescription. As medical devices in Canada, cosmetic contact lenses would be subject to specific requirements for licensing, manufacturing, labeling, and instructions to improve their safety before they go on the market. The proposed changes to the Medical Device Regulations are being published in Canada Gazette I on October 18 to begin consultations. In addition, new guidance documents and new application forms will be posted on the Health Canada website for a 75-day comment period.  Read more.

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