As Health Canada continues to tweak its Medical Device Single Audit Program (MDSAP) with the goal of transitioning ahead of its compliance deadline, several issues facing small- to medium-sized device companies remain unaddressed.
The requirement of obtaining a MDSAP certificate for companies to legally sell devices in the Canadian market has triggered a “wait-and-see mode” among those that are smaller, including startups, Christine Zomorodian, principal at Gish Consulting, told Focus.
The consulting firm has heard from clients that are no longer planning a market entry in Canada, despite the most recent changes to the program
in which the regulatory authority will allow the use of surveillance audit certificates as temporary substitutes for MDSAP certificates, Zomorodian said. And while some are delaying their entry into the Canadian market, others have reportedly been planning an exit, at least for the time being.
Last October, Health Canada also implemented reductions to audit times
for small- to medium-sized device companies with a presence in the Canadian market. Even so, industry has made one thing clear: the Canadian market will not be experiencing the introduction of new technologies as rapidly as other markets, Zomorodian noted.
Patrick Hope, executive director of the Medical Imaging and Technology Alliance (MITA), told Focus
the regulatory body “should be commended for its flexibility” in its efforts to address the challenges that have emerged in companies’ preparations for MDSAP compliance.
Health Canada staff have been “working hand in hand with all stakeholders,” said Hope, who also serves as the chair of the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA). “They’ve worked really hard to make this as easy as possible for manufacturers to comply.”
However, some companies are in a difficult position because Health Canada set a deadline of 1 January 2019 for implementing the program—a cornerstone of the International Medical Device Regulators Forum’s (IMDRF) initiative for global harmonization of device regulations.
And while the program was intended to facilitate auditing processes by allowing a single audit to satisfy the regulatory requirements of the jurisdictions that form part of the MDSAP consortium, which currently include the US, Canada, Brazil, Japan and Australia, no other regulatory body outside of Canada is requiring device companies to adhere to such a deadline.
Setting this deadline led to “a mad rush” for companies to get into compliance, Hope said. He added that the concerns remain with a lack of auditing organizations, lack of training to ensure consistency across all auditing organizations, as well as a lack of resources to support their work in a timely manner.
“We’ve heard feedback from our members about the inability to accommodate the high demand” of auditors that are MDSAP-certified, Hope said. “There’s not enough of them.”
Another frequent issue, according to Hope, relates to the “significant amount of time” between audit completion to issuing of certificates, with one company saying its audit had been completed in September but had yet to receive its certificate as of February.
These issues were echoed by Zomorodian’s clients and members of MEDEC—the national association of Canada’s medical technology companies—as MDSAP raised the bar for compliance in the five markets.
MEDEC’s head of communication, Gerry Frenette, told Focus
, the association and its members “continue to support the concept of MDSAP, however, some challenges have arisen with the transition,” including an “inability for companies to schedule audits due to lack of auditor availability, length of audit and the resources needed to facilitate it.” Yet another challenge is “the increased cost of the MDSAP audit.”
The changes implemented on 13 April 2018
are expected to aid companies that have faced scheduling difficulties with securing auditing organizations. Despite these changes and the audit time reductions, the challenges have remained the same, according to Frennette.
As such, companies that know they are not prepared to comply are putting any previous plans to sell their devices on the Canadian market on hold. This is because, as a smaller device firm told Zomorodian, this market “is not big enough to go through the expense right now.”
These companies also feel that “they don’t have the quality metrics developed to satisfy the requirements for MDSAP audits,” Zomorodian adds.
There is still time for even more changes to the Canadian MDSAP model to come.
Device companies are encouraged to share their unique situations with the regulatory body as industry associations continue to work in collaboration with Health Canada to address the remaining issues.
Large company, different story
In contrast to small- to mid-sized companies having difficulties with the new regulations in Canada, large companies have indicated that they are either already in compliance or will be before the deadline comes.
Several large companies with business in Canada are ready to reap the benefits of being MDSAP compliant, including some of MITA member companies, such as Fujifilm, GE, Canon Medical Systems Philips and Siemens—which is also a client of Gish Consulting.
According to Zomorodian, everything is going according to plans at Siemens, which is getting prepared for another audit this Spring.