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To sell medical devices in Canada, manufacturers must meet the Canadian Medical Devices Regulations set down by the industry regulator, which includes a Canadian Medical Devices Conformity Assessment System (CMDCAS).

Medical device

As a medical device manufacturer you will already be familiar with ISO 13485. To sell Class II, III and IV devices within Canada your ISO 13485 certification must have been independently audited by a CMDCAS Recognized Registrar.

SGS UK is Standards Council of Canada accredited as a CMDCAS Recognized Registrar. Our team of auditors reaches around the world, enabling you to partner with us wherever you are based to have your quality management system audited against ISO 13485 and the Canadian medical devices regulations.

The certification process must be completed before you apply for a Health Canada license and commence selling in Canada. For Class II devices the scope can exclude design but, for Classes III and IV, the scope must include design. Own brand labelers wishing to sell in Canada must also hold ISO 13485 certification under CMDCAS.

Our site audits will assess compliance to ISO 13485:2003 and parts of the Canadian regulations as necessary. The right medical certification at the right time is the key to winning new contracts, launching new products and entering new markets. With a strong reputation for technically correct advice and certification we have the expert knowledge and a global network of auditors which can help you achieve your objectives.

Bring your medical devices to market in Canada with a CMDCAS ISO 13485 certification audit from SGS.