Health Canada Revises Medical Device Safety Regulations
Recent changes to patient safety standards have had an impact on medical device companies looking to do business in Canada. New legislation – the 'Protecting Canadians From Unsafe Drugs Act' – has a reach that extends outside of the pharmaceutical sphere and touches on a number of areas of interest to device industry players.
Also known as 'Vanessa's Law,' after the daughter of a minister of parliament who died following a drug reaction in 2000, the scope of the legislation is primarily focused on providing Health Canada with greater power to track and remove potentially harmful products from the market.
Of particular interest to medical device companies is the renewed focus on post-market surveillance, which includes a more robust system for tracking adverse events as well as the ability for Health Canada to not only order recalls on products deemed unsafe, but to ask for companies to engage in new testing should additional risks or adverse events be reported post-market.
Transparency also plays a role in the new Act, with the requirement that clinical trial be added to a public registry, and a provision for Health Canada to share corporate information deemed to be 'confidential' with those judged to be vital to determining the safety of a medical device.
Finally, an initiative to clarify product labeling – using 'plain language' – has also been implemented. Health warnings must be clearly identified on product packaging, and companies are required to differentiate their packaging and naming from other medical devices in order to avoid the risk of confusion between two different treatments.
The cost of non-compliance with these new Canadian medical device regulations can be high. A new system of penalties associated with marketing products deemed to be unsafe now includes jail time, as well as fines topping out at $5 million per day - an increase that is 1000 times greater than the previous maximum fine.