It is approaching the deadline for the MDEL renewal, the Medical Device Establishment Licence in Canada.
According to the Guidance on Medical Device Establishment Licensing (GUI-0016), by 1 April each year all MDEL license holders must submit an application for the annual renewal of the license, in order to ensure compliance with regulatory requirements, to keep information up to date and to allow the activities of import or distribution of Medical Devices for human use in Canada.
Moreover, Health Canada has updated the charges of commissions (fees) in relation to medicines and MDs, applicable from 1 April 2021.
What is MDEL and what happens in the event of non-renewal?
According to the regulation in force, to be able to market their devices in Canada, Manufacturers must obtain a license which varies according to the risk class of the device.
There are two types of licences issued by Health Canada: the Medical Device Establishment Licence (MDEL) and the Medical Devices License (MDL).
The Medical Device Establishment License (MDEL) is an establishment licence issued to Class I Medical Device Manufacturers and to MD Importers and Distributors of all four Classes, to import or distribute a product in Canada.
This licence may be obtained if the establishment meets all the MDEL regulatory requirements of Health Canada.
Each year, it is mandatory to apply for the annual renewal of the MDEL, even if no changes have been made to the content of the licence.
In the event that the deadline of 1 April is not respected, Health Canada will cancel the MDEL with consequent blockage of the commercialization on the territory.
Commissions in force since 1 April 2021
On December 5, 2020, in the Canada Gazette, Part I it was published the new notice on the updated commissions in relation to Medical Devices and Medicines which shall apply from 1 April 2021.
The tariffs have been updated according to the consumer price index and they shall apply to the applications relating to Medical Device Licence and Establishment Licence.
Do you need support for MDEL license renewal?
Thema experts are available to assist those who want to market Medical Devices and IVDs in Canada, providing support in obtaining and renewing MDEL and MDL licences.
Contact us for further information.
Sources:
Guidance on Medical Device Establishment Licensing (GUI-0016)
