Medical Device Link.

Originally Published MDDI February 2003

NEWSTRENDS

Stuart Logie

As 2002 drew to a close, Canadian authorities found themselves in a tough spot. On one side, they had a January, 2003, deadline to comply with the new Medical Device Regulation requirement for quality system certificates; on the other, a mid-2003 revision of the international quality standard for medical devices. They have now said they will accept either certificate from U.S. device makers for three years.

“We will respect the three-year transition period proposed by the ISO TC 210 working group for the adoption of the revised ISO 13485 standard,” Egan Cobbold, a Quality Systems Officer with the Medical Devices Bureau in Health Canada told MD&DI.

“That means from U.S. medical device makers we will accept ISO 13485:1996 and 13488:1996 from approved registrars until mid-2006.”

Indeed, Health Canada is showing considerable flexibility to foreign medical device makers as it moves to harmonize its medical device regulations with international quality rules. Health Canada’s quality system rules for medical devices follow international rules, with the exception of specific requirements for recall procedures and reporting. 
Health Canada already has made a number of changes to the Canadian Medical Devices Conformity Assessment System (CMDCAS), the program that will grant quality system certification for makers of Class II, III, and IV medical devices. It dropped the Regulatory Profile as a CMDCAS requirement, and more importantly it jettisoned the Made-in-Canada component of the CMDCAS registrars program. 

That component would have seen all medical device manufacturers—both foreign and domestic—obtaining quality system certification only from Canadian incorporated registrars. Now, Health Canada is prepared to accept foreign incorporated registrars so long as the Standards Council of Canada accredits them. “We smartened up on that issue,” said Cobbold. 
“We realized that most registrars are multinational organizations anyhow.”

But while Canada is a partner of the Global Harmonization Task Force (GHTF), this hasn’t prevented Canada’s own harmonization process from being mired in confusion and controversy. “Health Canada went at this program backwards and this has created a lot of confusion in the medical devices industry,” explained Kevin Murray, vice president of regulatory affairs for MEDEC, a medical devices trade association based in Toronto. “The industry has been aware of the quality systems requirement since 1998, yet we only knew about the registrars some months ago. The guidance documents are still in draft form, and the government has still to pass the legislation that will amend the Medical Device Regulations requiring quality system certificates.” Murray added that the deadline for compliance is past, and the government is still putting things in place. 

In fact, Health Canada had abandoned its earlier July 2001 deadline for quality system certification because of delays in amending the regulations. It then called on medical device makers instead to follow voluntary compliance before the new January 2003 deadline. The industry response disappointed Canadian officials. “The compliance period wasn’t used as widely as we thought it would be, and when it was used the certification was wrong, the standards were wrong, and in general there was a lack of awareness of what was expected,” said Cobbold.

The current deadline for quality system compliance continues to be a nagging source of confusion. Last August, Health Canada included a note in the license renewal packaged sent to all licensed medical device manufacturers selling in the Canadian market. The letter informed them of new regulatory quality system requirements that would come into force on January 1, 2003. However, some auditors have told manufacturers that they could wait until November 1, 2003, before conforming to the new regulations.

“It should be pretty clear,” explained Cobbold. “If you are applying for a new license after January 1, 2003, then you must include a quality system certificate from an approved registrar. If you have an existing license, then you need to show a quality system certificate at the time of license renewal, which occurs on November 1, 2003.”

But Cobbold warns that this “is not another grace period. We expect all medical device makers to be actively complying with quality systems certification as we speak.”

That may be a problem. So far there are only eight Standards Council of Canada–recognized registrars able to perform CMDCAS quality system audits, with another eight in waiting. MEDEC fears the delays and the number of available auditors could create bottlenecks that would further delay the introduction of certain products into the Canadian market.

“The process of quality system certification can take from 12 to 18 months,” said MEDEC’s Murray. “And there’s no guarantee that the registrars in waiting will still be there when we need them. That means there clearly isn’t enough coverage for the market spectrum.” 

Already some medical device manufacturers have informed the government that they intend to exit the Canadian market since their market share cannot justify the added expense and delays due to the quality system certification.

“If that involves a company with a unique technology, that really represents a loss for the Canadian healthcare market,” said Murray.
For more info: http://www.scc.ca/ standards/cmdcas/index_e.html. Send email inquiries: ISO13484CMDCAS _SCECIM@hc-sc.gc.ca.

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