I distribute products in Canada, what do I have to do?
MDEL is the licence to distribute medical devices in Canada. It can be applied for at the Canadian health authority „Health Canada“ . For higher-classified medical devices, a product licence (MDL – Medical Device Licence) is also required.
Manufacturers who hold an MDEL for Canada were contacted by Health Canada in December and sent the Annual Licence Review (ALR) Package . If your registered products are to continue to be distributed in Canada, the annual reports must be submitted to the Canadian authority by 31 March 2022.
I have not yet received an ARL, what do I need to do? ARL erhalten, was ist zu beachten?
If you are the holder of an MDEL but have not yet received an ALR , be sure to check your SPAM folder or write to the authority or us If you do not submit the notification, your MDEL will be cancelled.
Please also note the fee schedule of the Public Health Agency of Canada.
The standard annual fee from 1 April 2022 is CAD 4,737.00. However, you should check whether you qualify for a small business discount of 25%. A small business is any company, including any associated companies, with:
- less than 100 employees or
- annual gross receipts between 30,000 and 5 million dollars (CAD)
The total number of employees and the annual gross receipts of the entire company are taken into account when calculating the size of the company. This includes all employees and revenue, regardless of geographic location (domestic and international) or product line. The fee reduction for small businesses applies to both domestic and international companies. Further information can be found here. The small business status must be reapplied for annually.
Before applying, 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.
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