Quality Systems ISO 13485 and ISO 13488
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 requires Class II medical devices to
be manufactured under CAN/CSA ISO 13488-1998, and Class III and IV medical
devices to be designed and manufactured under CAN/CSA ISO 13485-1998.
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
Notices
Policies
Recognized Registrars Listing
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