Notice: GD207: Guidance on the Content of ISO 13485 Quality Management System Certificates issued by Health Canada recognized registrars

March 14, 2017
Our reference number: 17-102518-961

Health Canada is pleased to announce the release of the revised guidance document GD207: Guidance on the content of ISO 13485 Quality Management System Certificates issued by Health Canada recognized registrars.

This documentprovides guidance to manufacturers of Class II, III, or IV medical devices and registrars recognized by Health Canada on the essential information that Health Canada requires to be displayed on ISO 13485:2003 or ISO 13485:2016 quality management system (QMS) certificates issued under the Canadian Medical Devices Conformity Assessment System (CMDCAS). This document has been recently revised to include reference to CAN/CSA-ISO 13485:16, Medical devices - Quality management systems - Requirements for regulatory purposes, and other new or updated international standards.

All manufacturers of Class II, III, and IV medical devices must complete the transition to ISO 13485:2016 by March 1, 2019. Health Canada is encouraging manufacturers to begin the transition process in a timely manner and is therefore accepting ISO 13485:2016 QMS certificates effective immediately. Please note that the Medical Devices Regulations will be amended to reflect the revised standard by the 2019 transition date.

Medical Device Single Audit Program (MDSAP) Transition Reminder

As stated in Health Canada notices dated January 2014 and January 2015, Health Canada intends to replace the current CMDCAS program with the MDSAP by January 1, 2019. Health Canada will continue to accept certificates issued under both CMDCAS and MDSAP during this transition period; however, as of January 1, 2019, Health Canada will only accept certificates issued under MDSAP (more information is available at Notice: MDSAP Transition Plan - FAQ). Consequently, the GD207 will also be withdrawn at that time.

All revisions to this guidance document are effective immediately.

Questions or concerns regarding this guidance document should be directed to:

Quality Systems Section
Medical Devices Bureau
Health Canada
Holland Cross, Tower A
11 Holland Avenue Suite 511
Ottawa, Ontario
K1A 0K9

Phone: 613-952-8250
Fax: -613-954-7666
Email: QS_MDB_HC@hc-sc.gc.ca