Health Canada
CMDCAS
If you intend to export a Medical Device into Canada you are required
to:
* Comply with the relevant sections of the Canadian Medical Devices
Regulation
* Comply with the relevant requirements of ISO13485
* Have your Quality Management System certified by a auditing body
recognized by Health Canada
Notable unique requirements of Health Canada are:
* Prohibition requirements
* Medical Device Licensing requirements
* Annual submission of changes to the registered Medical Device
* Record keeping by both the Distributor and the Manufacturer
* Vigilance actions by both the Distributor and the Manufacturer
AQAS can assist you in documenting the regulatory requirement, adjusting
the current Quality Management System to comply with the Canadian
Medical Devices Regulation and in the licensing application. Call now
AQAS can also assist you in the transition from ISO9001:2000 to
ISO13485:2003
E-mail: sales@aqas.com.au