canada
Regulatory Authority

Health Canada (HC)

Classification

I, II, III, IV

Quality system

As of January 1, 2019, the CAN/CSA-ISO 13485:2016:03 and CAN/CSA-ISO 13485:2016:16 certificates issued by the CMDCAS are no longer accepted. Therefore, all manufacturers of Class II, III and IV devices must switch to the Medical Device Single Audit Program (MDSAP) to obtain the ISO 13485:2016 certificate (Ref. CAN/CSA-ISO 13485:2016:16, see amendment SOR 2019-44, s. 2) following a successful audit by an accredited Auditing Organization.

Medical Devices and IVD Devices are subject to registration.

To market their devices in Canada, manufacturers must obtain a license. There are two types of licenses issued by Health Canada: the (1) Medical Device Establishment Licence (MDEL) required for Class I Medical Devices and the (2) Medical Device Licence (MDL) for all the other classes.
The class I medical device manufacturer who intends to sell their Medical Devices directly to the user in Canada must obtain an MDEL. The manufacturer who intends to sell to the importer on site must obtain it if he is not already in possession of it.
Class II, III and IV Medical Device manufacturers who intend to place their devices on the Canadian market must have an MDL following the issuance of the ISO 13485:2016 certificate.

Applicant

Foreign manufacturer for the MDL. Foreign manufacturer and/or importer for the MDEL.

Timeframe and fees

Time frame for obtaining the MDEL: 120 calendar days.
Time frame for obtaining the MDL: Class II – 15 days (calendar), Class III – 75 days; Class IV – 90 days.

Validity

Both MDELs and MDLs must be renewed annually, otherwise they will be cancelled.
The MDEL renewal (class I) is done by sending the Annual Review application and paying the fees by April 1st.
The MDL renewal (classes II, III and IV) is done by declaring the quantity of sold devices, upon which the fee to be paid for renewal is calculated, due by November 1st of each year.

Labelling and documentation language

For Medical Devices sold to the public, the labelling must be provided in both English and French.
For Medical Devices for professional use, the labelling must be provided in English or French.

Useful information

The MDL (approval licence) is an approval of the device, while the MDEL (factory license) is a permit given to the manufacturer/distributor/importer company. The foreign manufacturer who intends to sell their Medical Devices in Canada does not need a Local Representative.

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