IVD Technology
Magazine
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Originally published September, 1997
Editor's Page
Border-line mentality
Diagnostics manufacturers are accustomed to the notion that it is expensive to bring cutting-edge technologies to market. There are substantial costs involved in creating and testing new products and in meeting essential regulatory requirements. But for IVD firms doing business in Canadathe world's fourth-largest market for diagnosticsit's about to become a whole lot more expensive.
That was the message delivered in Toronto last month by Steve Sanders, vice president for quality assurance and regulatory affairs at bioMérieux Vitek (Hazelwood, MO), at the annual meeting of the Clinical Laboratory Management Association. The new expenses come as part of a cost-recovery scheme in Canada's newly proposed system for regulating medical devices and IVDs, scheduled to become effective on February 1, 1998. The preliminary schedule of fees, delivered to manufacturers in July, calls for annual establishment registration fees as well as annual fees to renew the registration of each medical product on the Canadian market. For a company of moderate size with even a few products, Sanders estimated, the total cost of complying with the new system could be as much as $50,000 per year.
"If I were a Canadian citizen, I'd be very upset about this proposal," Sanders said. "Manufacturers will almost certainly attempt to recover their increased costs from the Canadian national health service, Health Canada, which means that the costs will simply be passed from one branch of the government to another."
Sanders predicted that the effects of the new scheme will include increased time to market, greater regulatory affairs costs, higher breakeven points for new products, and squeezed profits. He also suggested that many manufacturers will be reviewing their current product lines to determine whether their Canadian business can remain profitable.
Industry associations, including Medical Devices Canada and the Association of Medical Diagnostics Manufacturers (AMDM), have submitted comments on the proposed regulatory system. But overall, industry reaction to the proposed fee-recovery scheme has been modest. There is some chance that the scheme will be modified before its scheduled final publication in February 1998, but without concerted industry effort to remove the proposed fees, it seems likely they will remain.
I'm looking forward to Sanders' update on the Canadian proposal at the AMDM annual meeting, which will also feature more than a half-dozen speakers from FDA's Center for Devices and Radiological Health. The meeting will be held in Rockville, MD, on October 2021. Manufacturers that export to Canada should make a point of attending this meeting and becoming informed on the changing regulatory system. For further information, contact AMDM at 202/637-6837.
Steven Halasey
