Making better use of human and financial resources is a challenge to which most organizations can relate. In the arena of public health and safety that challenge is confounded: there is no acceptable margin of error when it comes to the design and manufacture of medical devices. Through partnerships with the Standards Council of Canada (SCC), regulatory authorities like Health Canada are able to benefit from SCC's expertise in conformity assessment, while realizing cost savings and maintaining required levels of scrutiny.
Third-party scrutiny is becoming the norm in the world of medical devices - which include everything from tongue depressors and catheters to cardiac pacemakers and artificial hips. Around the world, manufacturers and regulators were converging on the use of ISO-based quality systems for the control of the design and manufacture of medical devices, says Egan Cobbold, Quality Systems Officer with the Medical Devices Bureau at Health Canada, which regulates medical devices in Canada.
In a bid to harmonize Canada's medical device regulations with those of our international trading partners, in 1998, Health Canada introduced new regulations requiring medical devices sold in Canada to be designed and manufactured under a registered quality management system (QMS) that conforms to international standards ISO 13485 or ISO 13488. On January 1, 2003 the quality system provisions, the remaining component of these new regulations, will come into effect.
Regulators in other countries who have introduced similar regulations have also developed their own accreditation systems, but Health Canada decided instead to work with the Standards Council to implement the regulations. Setting up an accreditation system is "a very big job, it's time consuming, it costs a lot of money," Mr. Cobbold explains: just conducting the yearly audits of the approximately 2,600 manufacturers internationally that sell medical devices in Canada would require employing a few hundred auditors. He says that with the Standards Council's expertise, knowledge and training in the business of accreditation, it made more sense for Health Canada to work with the Standards Council rather than set up its own program.
The result is the Canadian Medical Devices Conformity Assessment System (CMDCAS). As part of the system, the Standards Council accredits QMS registration organizations to register manufacturers' quality management systems to the appropriate standards. Health Canada oversees the process and provides technical expertise. Under the CMDCAS, Health Canada and the Standards Council have so far been able to work with over a dozen registration organizations globally, and have trained more than 350 auditors.
Mr. Cobbold describes the CMDCAS as a "very elegant model" ... it takes advantage of the Standards Council's resources, it allows the medical device industry to use independent third parties around the world, and provides opportunities for joint-audits by combining the number of audits to which medical devices manufacturers are subjected in order to meet various regulatory requirements.