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Drugs and Health Products

Quality Systems ISO 13485

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 require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. 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

The following Training Modules summarize the contents of the Study Guide GD211: Guidance on the content of quality management system audit reports and are available as a convenience to the user. The Training Modules are available in Microsoft PowerPoint and Portable Document Format as an alternate format to the Study Guide.

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 [2006-03-15]
  • Update on the June 10, 2005 Cessation of Recognition of Orion Registrar Inc. as a Registrar by Health Canada [2005-08-25]
  • Cessation of Recognition of Orion Registrar inc. as a Registrar by Health Canada [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. [2003-11-20]

Policies

Recognized Registrars Listing