FOR IMMEDIATE RELEASE: 2001-08-09

First registrar qualified to new medical device requirements

OTTAWA - The Standards Council of Canada has qualified TÜV Management Service of Danvers, Massachusetts, to the requirements of the Canadian Medical Devices Conformity Assessment System (CMDCAS), part of a new federal licensing system for medical device manufacturers. TÜV is the first quality management systems registrar to receive this qualification.

Under new federal medical device regulations, as of January 1, 2003 certain types of medical devices will have to be manufactured under a registered quality management system (QMS) that meets the requirements of ISO 13485 or ISO 13488 in order to be sold in Canada. ISO 13485 and ISO 13488 are international standards that provide specific requirements for the application of the ISO 9000 QMS standards to the medical devices industry.

The CMDCAS program was developed by Health Canada and the Standards Council to implement these new regulations. The Standards Council's role is to qualify accredited QMS registration organizations to register manufacturers' quality management systems to the appropriate standards.

"CMDCAS is an example of the potential which standards systems offer to regulators", said Don Wilson, director of conformity assessment for the Standards Council. "By incorporating the existing QMS accreditation and registration infrastructure into the medical device regulations, Health Canada is able to provide an increased level of scrutiny over the manufacturing process without significantly increasing costs to either the federal government, the manufacturer or the user."

"Becoming the first registrar to be accredited to CMDCAS is a tribute to the dedication the TÜV Management Service team brings in providing services that add value to our clients' organizations," stated Mark Alpert, Senior VP, TÜV Management Service. "Achieving CMDCAS allows TÜV to provide our clients on a global scale the certification necessary to meet the January 1, 2003 deadline of achieving SCC accredited ISO 13485 or ISO 13488 certification."

To become accredited and qualified, a registrar must meet the Standards Council's criteria related to such issues as qualified staff, the existence of a documented functioning quality system, proper record keeping, continual improvement, and freedom from conflicts of interest. TÜV's qualification follows a comprehensive assessment by the Standards Council of Canada.

In addition to its CMDCAS qualification, TÜV was also accredited by the Standards Council as a QMS registration organization.

TÜV Management Service, which employs over 240 professionals throughout North America, is the registrar division of TÜV America Inc. TÜV Süddeutschland AG (Munich, Germany), the parent company, employs over 9,000 professionals in over 30 countries. Globally, TÜV has issued over 24,000 product and 12,000 quality management system certifications. For more information on TUV, please visit their web site at www.tuvglobal.com.

The Standards Council of Canada is a Crown corporation with the mandate to promote efficient and effective standardization. For more information on CMDCAS or the Standards Council's accreditation programs, please visit www.scc.ca, or contact the Standards Council's Conformity Assessment Branch at [email protected].

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