CMDCAS ISO Certificate and Medical Device Establishment License

Health Canada
Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. 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.

	Download ISO_13485: 2003 CMDCAS Adobe Acrobat Format			Download Medical Device Establishment License Adobe Acrobat Format

For more information, please contact:

Mrs. Jodi Hutchins
Quality Assurance/Regulatory Affairs Director
Phone Extension 156
jodih@orthotechnology.com