Update on the JCessation of Recognition of Orion Registrar Inc.

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.

Notice: Transition to the Revised Version of ISO 13485 and its impact on the Compliance to the Quality Management System Requirements of the Canadian Medical Devices Regulations.

GD208/Rev0 - Guidance on the Acceptance of Quality System Certificates before and after Janu.

GD210: ISO 13485:2003 Quality Management System Audits Performed by Health Canada Recognized Registrars.

GD207: Guidance on the content of ISO 13485 quality management system certificates issued by Health Canada recognized registrars.

Guidance Document GD211: Guidance on the Content of Quality Management System audit reports.

CDRH Learn Portal - Online video training on GD211.

GD211 Training, Module 5 - Conclusions.

GD211 Training, Module 4 - Audit Findings.

GD211 Training, Module 3 - Information about the audit.

GD211 Training, Module 2 - Information about the manufacturer.

GD211 Training, Module 1 - Introduction.

The Training Modules are available in Microsoft PowerPoint and Portable Document Format as an alternate format to the Study Guide. 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.

Study Guide GD211: Guidance on the content of quality management system audit reports.

Form F202 Submission of a New or Modified Quality Management System Certificate.

Form F201 Change of a Manufacturer's Registration Status.

These quality system requirements came into force on January 1, 2003. There are no regulatory quality system requirements for Class I medical devices. 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.

The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system.

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. Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement.

En iso 13485 2016