New medical devices regulations incorporate quality management principles

2001-08-02

The Canadian Medical Devices Conformity Assessment System (CMDCAS) will support the incorporation of the quality management principles of ISO 13485 and ISO 13488 into Canada's regulatory system for medical devices. Find out more about this new system, and the roles of the Standards Council and Health Canada.

New quality management systems provisions in federal medical device regulations, scheduled to take effect on January 1, 2003, will require some devices to be manufactured under a registered quality management system (QMS).

Under the new regulations, manufacturers of certain types of medical devices will need to have a QMS that meets the requirements of ISO 13485 or ISO 13488 in order to obtain a license to sell these devices in Canada. ISO 13485 and ISO 13488 are international standards that provide specific requirements for the application of ISO 9000 to the medical devices industry.

The Canadian Medical Devices Conformity Assessment System (CMDCAS) has been developed by Health Canada in collaboration with the Standards Council to implement these new regulations. As part of the system, the Standards Council will qualify accredited QMS registration organizations to register manufacturers' quality management systems to the appropriate standards.

In the pages and sites listed below, you'll find more information on CMDCAS and what Health Canada and the Standards Council are doing to help registrars and manufacturers comply with the new regulations.

• General information
• Information for QMS registration organizations
• Information for manufacturers
• Interpretations
• Other links

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General information

New Program Links Medical Devices Regulations to Quality System Registration 
A news release announcing the agreement between Health Canada and the Standards Council

Medical Device Regulations

• The Medical Device Regulations, as passed on May 7, 1998: HTML  PDF 
• An amendment changing the date on which the QMS requirements come into effect to January 1, 2003, in order to provide enough time for the registration system to be established: PDF

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Information for QMS registration organizations

Click here to access the restricted Workspace for the CMDCAS Registration Body Forum.

For additional information regarding qualification to the CMDCAS Program, or to receive an application package, please contact [email protected].

Policy on the Canadian Medical Devices Conformity Assessment System (CMDCAS) (Health Canada): HTML PDF
Health Canada's requirements for qualification under CMDCAS

Voluntary Implementation Phase of the Quality Management System Requirements under the Medical Devices Regulations

Guidance on the Content of ISO 13485 and ISO 13488 Quality System Certificates Issued by CMDCAS Recognized Registrars: HTML, PDF

Guidance on the Acceptance of Quality System Certificates before and after January 1, 2003: HTML, PDF

Guidance on ISO 13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars: HTML, PDF

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Information for manufacturers

CMDCAS registration organizations
A complete list of QMS registration organizations which have received or applied for CMDCAS qualification through the Standards Council

The standards
The CMDCAS program incorporates the requirements of two international standards:

• ISO 13485:1996, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001
• ISO 13488:1996, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002

These standards have been adopted by the Canadian Standards Association (CSA) and approved as National Standards of Canada by the Standards Council of Canada, under the following reference numbers:

• CAN/CSA-ISO 13485-98, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001
• CAN/CSA-ISO 13488-98, Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002

The content of the international and corresponding Canadian versions of the standards is identical.

To purchase the international versions, contact the Standards Council's sales agent, Global Engineering Documents. To purchase the Canadian versions, contact CSA.

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Other links

CMDCAS Training
CMDCAS training is coordinated through Accademia Qualitas. Together with Health Canada, Accademia Qualitas conducts several CMDCAS training courses annually.

Health Canada's Therapeutic Products Directorate (TPD)
TPD is the Canadian regulatory authority for medical devices. In collaboration with the Standards Council, it has developed and is implementing the CMDCAS program.

Global Harmonization Task Force (GHTF)
The GHTF is an international group of medical device regulators and representatives of the industry. Its purpose is to encourage the harmonization of regulatory practices. GHTF guidelines for quality requirements and auditing have been incorporated into the CMDCAS program.