Health Canada Beefs Up Medical Device Policies


Health Canada has finally come up with a comprehensive blueprint to strengthen the policies related to medical devices, ranging from defibrillators to breast implants, like a latest online database carrying all information related to device-related health incidents.

On Thursday, the regulator said that it is also planning to create an advisory committee on the health of women that will focus on vaginal meshes, breast implants, and contraceptive devices. Stern requirements are likely to put pressure on device makers to inform Health Canada within three days, if foreign regulators warn them about any severe risks associated with their products.

The chief medical adviser for Health Canada, Dr. Supriya Sharma said that they need to pull up their socks and make extra efforts if they want to strengthen their work. Dr. Sharma added that the plan is expected to prove helpful in ensuring that the medical devices used in Canada meet the highest possible standards for quality, safety, and effectiveness.

The move has been taken following a revolutionary investigation that disclosed previously hidden federal data, which showed that more than 1,400 individuals in Canada have lost their life since 2008 in issues that involved various medical devices, while nearly 14,000 reported injuries.

The investigation discovered that device placed inside individuals in Canada without testing in humans were linked to severe health complications. Also, as a result of a lack of public reporting, recurring problems weren’t revealed to Canadians and their doctors. In the US, medical device ‘adverse events’ gets published online, but no such data becomes accessible for patients in Canada or their physicians. Health Canada needs to do something to ensure well-being and health of all Canadians.

Medical devices have changed countless lives worldwide, and the numbers are likely to rise, and as they do, Health Canada is putting their best foot forward to keep up.

There are many reforms Health Canada is planning to roll out in the coming year. Some of them are:

  • Health Canada will become more rigorous in approving new medical devices for implantation into patients in Canada.
  • For the first time ever, the nearly 776 hospitals in Canada will have to report medical device incidents. So far, just the importers and manufacturers were required to report medical device incident details.
  • Health Canada will get the right to ask device manufacturers to carry out safety tests, assessments, and researches on their products.
  • The regulator will also add a couple of “investigational analysts” and eight inspectors to revert to “higher-risk incidents.” It will also increase the number of foreign inspections of device plants to 95 from 80, outside Canada, starting in April.
  • Last but not the least, the regulator will make more of the proof supporting medical devices accessible to the public.


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