Health Canada Draws Criticism for Handling of Medical Device Applications and Safety

Medical device companies operating in Canada should be aware that the country’s Office of the Auditor General recently released its findings that Health Canada’s performance in regulating medical device products in that country has been deemed “unsatisfactory.”  The revelation comes on the heels of findings of two previous audits which pointed out similar shortcomings in how the ministry has been protecting public safety.

Specifically, the Auditor General’s office has leveled charges that Health Canada has been remiss in providing market surveillance and inspection services at the level necessary to guarantee that medical devices that have been approved for sale are actually offering the benefits as advertised.  By the same token, Health Canada’s mechanism for monitoring the incidence of adverse events and complaints from patients is also lax, in terms of its ability to verify that manufacturers have actually taken action to address required changes to a product or which has been identified as not meeting regulatory requirements.

These serious problems discovered by the Office of the Auditor General are on top of a number of other issues, including the claim that in almost half of all cases, Health Canada is unable to meet its own pre-market review deadlines according to the standards that were established with the Canadian medical device industry.  The Auditor General’s office recognized that, like the FDA and CDRH to the south, Health Canada is being hit by the two-pronged attack of inadequate funding and increasingly complex device applications.  However, the ministry’s poor performance delays access to important medical technology required by Canadians, despite the fact that many of the medical devices in question have already been approved in other global markets – approvals that Health Canada does not take into account during its own review process.

What does this mean for medical device companies operating in the Canadian market?  If Health Canada takes the recommendations offered by the Office of the Auditor General to heart – namely, the establishment of a post-market activities baseline that takes into account facilities inspections, more accountability in incident reporting, and the hiring of employees who are better capable of keeping abreast of technological and scientific advances – then the Canadian market may become more demanding in terms of its regulatory environment.  At the same time, a more efficient and informed Health Canada apparatus would also allow medical device manufacturers to enter the market faster and ostensibly with lower costs, which could balance out any additional time required to meet more strictly-enforced policies and regulations.

That being said, although there is a pressing need for Health Canada to improve its management of medical device applications, the Auditor General report echoes similar sentiments made all the way back in 2004, and then again several years later.  With no concrete action having been taken to address these concerns in the past, it is uncertain how quickly the ministry will respond to the more recent findings.

Benjamin Hunting
MDCI Blogging Team