April 1, 2024, represents a very significant date for the Medical Devices market in Canada. First, from this date, modified tariffs will come into force for applications, such as device registration, involving Medical Devices.
In addition, holders of a Medical Device Establishment Licence (MDEL) shall apply for a review of their licence every year by April 1 excluding holders of a licence with a suspended MDEL.
Fees will be subject to a general increase; for example, a licence application for a Class II device will go from a cost of $589 to $615, for a Class III device from $12,987 to $13,559, for a Class IV device from $28,165 to $29,40, the establishment licence for Medical Devices will cost $5,283 and no longer $5,060.
Concerning the MDEL (Medical Device Establishment Licence), manufacturers must apply for a review of their licence by April 1, 2024, either to apply for a new licence or to apply for amendments or cancellations. If a manufacturer has ceased marketing activities in Canada and therefore wishes to cancel its licence of establishment, it is still obliged to notify this by requesting cancellation by April 1, 2024. What has just been described for manufacturers also applies to distributors.
In conclusion, the Canadian regulatory framework shows that it is constantly evolving to ensure the development of an innovative and competitive market. In this sense, the proposed changes aim to strengthen the regulation and supervision of the Canadian regulatory agency, improving its monitoring and evaluation capacity.
>>> Through the services of strategic-regulatory consulting and document pre-screening Thema supports the registrations with Health Canada (Medical Device Licence and Medical Device Establishment Licence).
To register class II, III and IV devices, it is necessary to adapt the quality management system to the Canadian regulatory requirements and obtain the MDSAP certificate. Rely on our experts to adjust and receive support before, during and after the auditing organisation’s inspection visit.
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