Medical Device Establishment Licence (MDEL)
Manufacturers holding a Medical Device Establishment Licence (MDEL) for Canada were contacted by Health Canada in December and the Annual Licence Review (ALR) Package was submitted with it.
If your registered products are to continue to be distributed in Canada, the annual report must be submitted to the Canadian authority by 31st, March 2021.
If you are an MDEL holder but have not yet received an ALR, be sure to check your SPAM folder or write to the Authority or us. Otherwise, if you do not submit the notification, your MDEL will be cancelled. It is also important to note the new fee schedule of the Public Health Agency of Canada, which has been in effect since April 2020. The standard annual fee is CAD 4,590.00, but you should check to see if you qualify for a small business discount. You can find the business size and turnover requirements here. The calculation of company size includes the total number of employees and the annual gross turnover of the entire company. This includes all subsidiaries, regardless of geographic location or product line. You must apply for small business status on an annual basis.
Before applying for this, you should familiarise yourself with the details at Health Canada or contact our experts. We will also be happy to help you in Canada and take these steps off your hands if necessary.