Quality Systems ISO 13485 and ISO 13488

Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

The Medical Devices Regulations requires Class II medical devices to be manufactured under CAN/CSA ISO 13488-1998, and Class III and IV medical devices to be designed and manufactured under CAN/CSA ISO 13485-1998. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on
January 1, 2003.

	Forms
	Guidance Documents
	Notices
	Policies
	Recognized Registrars Listing

Forms

	Form F202 Submission of a New or Modified Quality Management System Certificate Date: 2005-06-15
	Form F201 Change of a manufacturer's registration status Date: 2005-02-18

Guidance Documents

	GD210/RevDR - DRAFT - ISO 13485 and ISO 13488 quality system audits performed by CMDCAS recognized Registrars Date: 2003-01-09
	GD207/Rev0 - Guidance on the Content of ISO 13485 and ISO 13488 Quality Systems Certificates issued by CMDCAS Date: 2003-01-09
	GD208/Rev0 - Guidance on the Acceptance of Quality System Certificates before and after January 1, 2003 Date: 2003-01-09

Notices

	Update on transition to the revised versions of ISO 13485 and its impact on the compliance to the quality system requirements of the Canadian Medical Devices Regulations Date: 2006-03-15
	Final Decision - Cessation of Recognition of Orion Registrar Inc. as a Registrar by Health Canada Date: 2005-09-19
	Update on the June 10, 2005 Cessation of Recognition of Orion Registrar Inc. as a Registrar by Health Canada Date: 2005-08-25
	Cessation of Recognition of Orion Registrar inc. as a Registrar by Health Canada Date: 2005-06-10
	Transition to the revised version of ISO 13485 and it's impact on the compliance to the Quality Sytem requirements of the Canadian Medical Devices Regulations. Date: 2003-11-20

Policies

Policy on the Canadian Medical Devices Conformity Assessment System (CMDCAS) Quality Date: 2003-01-09

Recognized Registrars Listing

List of registrars recognized by Health Canada (HC) under section 32.1 of the Medical Devices Regulations (MDR) Date: 2005-04-21