New program links medical device regulations to ISO 9000

2000-10-01

The Pacific Accreditation Cooperation (PAC) welcomed new members and announced its intention to move into environmental management and product certification at its 7th annual meeting. 

Canadians rely on medical devices that range from tongue depressors to cardiac pacemakers to maintain and improve their health. That reliance is possible because of a regulatory system designed to ensure that medical devices are safe and effective. A recent agreement between the Standards Council of Canada and Health Canada's Therapeutic Products Programme (TPP) incorporates registration of a quality management system into that regulatory system and is expected to lead to even greater confidence in medical devices sold in Canada.

The agreement is part of a new regulatory system, which, following an implementation period commencing July 1, 2001, will come into force January 1, 2003. The system will require certain types of medical devices to be manufactured under a registered quality management system (QMS) - a sector specific adoption based on ISO 9000. The Standards Council has been chosen by Health Canada to qualify accredited ISO 9000 registrars to register these sector specific quality systems. Registration provides third-party verification that a QMS is designed and operated in accordance with the appropriate international standards.

The new regulations require certain types of medical devices to be manufactured under a registered QMS conforming to ISO 13485 or 13488, two standards that provide specific requirements to ISO 9000 in this field. The new quality system requirements of the Medical Devices Regulations are expected to improve device design and manufacturing controls.

This precedent-setting agreement assists Health Canada in maintaining its regulatory role while making effective use of the third-party registration system, which is an important component of the National Standards System.

The Standards Council of Canada is now accepting applications for this new program and will list accredited registrars that have been recognized under this scope in the ISO 9000 section on its web site once they are approved. For more information about the Therapeutic Products Programme and the new regulations, see Health Canada's frequently asked questions.  For more information about ISO 9000 and the Standards Council's role, see our ISO 9000 pages.