Regulatory Authority
Health Canada (HC)
Classification
I, II, III, IV
Quality system
As of January 1, 2019, CAN/CSA-ISO 13485:2016:03 and CAN/CSA-ISO 13485:2016:16 certificates issued by CMDCAS are no longer accepted. Therefore, all manufacturers of Class II, III and IV devices have to switch to the Medical Device Single Audit Program (MDSAP) to obtain the ISO 13485:2016 certificate (Ref. CAN/CSA-ISO 13485:2016:16, see SOR 2019-44, s. 2 amendment), following a positive audit by an accredited Auditing Organisation.
To be marketed in the Canadian market, all Medical Devices and IVDs must be registered with the Regulatory Authority – Health Canada (HC). Manufacturers must obtain both system and product certification.
With regard to system certification, MDSAP (Medical Device Single Audit Programme) certification is required. MDSAP is a programme that allows bodies recognised and accredited by the Regulatory Authorities of the five participating countries (U.S.A., Canada, Brazil, Japan and Australia) to conduct a single audit of Medical Device Manufacturers, to verify that they meet the Quality System management requirements of the relevant countries.
As regards product certification, there are two types of licences: the Medical Device Establishment Licence (MDEL) required for class I Medical Devices and the Medical Device Licence (MDL) for all other classes. Local Distributors and Importers must also request the MDEL.
Applicant
A foreign manufacturer wishing to sell its Medical Devices in Canada does not need a Local Representative.
Timeframe and fees
It takes at least 120 working days to obtain the MDEL. While regarding MDL, the time varies depending on the device class. Class II devices take at least 15 working days, Class III devices take at least 75 working days, and Class IV devices take at least 90 working days.
Validity
Both certifications must be renewed annually or they will be cancelled. The MDEL (Class I) renewal takes place by submitting the Annual Review application and paying the relevant fees by April 1.
MDL renewal (Classes II, III and IV) is done by declaring the number of devices sold, based on which the maintenance fee is calculated, to be paid by November 1 each year.
Labelling and documentation language
For Medical Devices for home use, labelling must be provided in English and French.
For Medical Devices for professional use, the labelling must be provided in English or French.
Useful information
April 1, 2024 is a very significant date for the medical device market in Canada, as revised fees for applications such as medical device registration have come into effect.
