Health Canada has revised their guidance document GD207, which covers the information displayed on ISO 13485 certificates issued by Health Canada recognized registrars. The new version of the document will take effect on January 2, 2008.

The most notable revision to GD207 is the replacement of references to ISO 13485:1996 and ISO 13488:1996 with ISO 13485:2003. Additionally, most of the references to "CMDCAS Recognized Registrar" have been changed to "Health Canada Recognized Registrar." The document also now includes examples of acceptable and unacceptable scope statements to aid in their development.

Any organization currently certified to ISO 13485:2003 under the CMDCAS program should take note of the changes, as it is the organization’s responsibility to design a scope statement that will meet the requirements of Health Canada. Intertek can guide its clients in developing an acceptable scope in accordance with those requirements.

Visit Health Canada's website to view the new GD207 or download it in PDF format.

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