Health Canada aims to improve medical device safety


Health Canada today announced new measures to improve the safety, efficacy and quality of medical devices.

Following the Implant Archives investigation, an increasing number of countries have stated that it will better track medical implants and warn patients about potential problems faster by creating or expanding medical device registrations.

The Health Ministry of Canada did not mention a registry, but said its three-part strategy aims to improve:

  • How medical devices reach the market
  • Monitoring and tracking devices already in use.
  • How much information Canadians have about medical devices.

Canada's Health Ministry said it will start setting up a new advisory committee of women's health experts for medicines and medical devices until January. Patients will be invited to participate.

The women's health committee will first examine devices such as breast implants, vaginal nets and contraceptive implants, Health Canada's chief medical officer Supriya Sharma told reporters.

Currently, some manufacturers give patients a card when a device that provides information is implanted. Sharma said it will add terms and conditions to licensing a "larger scope of devices" to provide more details about the device.

Health institutions will also be required to report incidents to Canada's Health Ministry and clinics will be encouraged to do so.

The regulator also proposed allowing health professionals to conduct "testing" of medical devices by June 2019. This brings medical devices in line with how drugs are regulated, Sharma said.

Device manufacturers will also be required to notify Health Canada within 72 hours when foreign regulators warn of serious implant-related risks.

CBC News is part of a global media collaboration with Radio-Canada, the Toronto Star and the Washington-based International Consortium of Investigative Journalists that have examined tens of thousands of medical devices and how they are made, approved and monitored by regulators all around the world.


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