Health Canada Registration Process

Class I Class II Class III Class IV
Manufacturers must comply with ISO 13485:2003 and the additional requirements of the CMDR.  The standards certification issued for use in Europe does not contain all the requirements for Canada.

Manufacturers must comply with ISO 13485:2003 and the additional requirements of the CMDR.  The standards certification issued for use in Europe does not contain all the requirements for Canada.

 Manufacturers must comply with ISO 13485:2003 and the additional requirements of the CMDR.  The standards certification issued for use in Europe does not contain all the requirements for Canada.
Manufacturers must have ISO 13485:2003 (re)audited by a Registrar accredited by Health Canada under CMDCAS.  Upon completion of the audit a new ISO 13485:2003 certificate will be issued. Manufacturers must have ISO 13485:2003 (re)audited by a Registrar accredited by Health Canada under CMDCAS.  Upon completion of the audit a new ISO 13485:2003 certificate will be issued. Manufacturers must have ISO 13485:2003 (re)audited by a Registrar accredited by Health Canada under CMDCAS.  Upon completion of the audit a new ISO 13485:2003 certificate will be issued.
Apply for a Medical Device Establishment License (if you are going to sell straight to the end user and not through a distributer). Apply for a Canadian Medical Device License. Apply for a Canadian Medical Device License. Apply for a Canadian Medical Device License.
Submit the MDEL application and pay the Health Canada fees.

Submit the MDL application, ISO13485:2003 certificate and pay the Health Canada fees.

 Submit the MDL application, ISO13495:2003 certificate, Premarket Review Document (following STED) and pay the Health Canada fees. Submit the MDL application, ISO13495:2003 certificate, Premarket Review Document (following STED) and pay the Health Canada fees.
Health Canada will then review the MDL application and Premarket Review Document.

Once the application is approved it will be posted on the Health Canada Website.

 Once the application is approved it will be posted on the Health Canada Website. Once the application is approved it will be posted on the Health Canada Website. Once the application is approved it will be posted on the Health Canada Website.

Once approved the manufacturer can sell your device in Canada.  The License does not expire; however, if the annual fee is not paid the license will be revoked.

 Once approved the manufacturer can sell your device in Canada.  The License does not expire; however, if the annual fee is not paid the license will be revoked. Once approved the manufacturer can sell your device in Canada.  The License does not expire; however, if the annual fee is not paid the license will be revoked. Once approved the manufacturer can sell your device in Canada.  The License does not expire; however, if the annual fees is not paid the license will be revoked.
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Health Canada Approval Process

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