The price for an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada varies according to the categorization of the medical device. We will compare the prices for both MDELs and MDLs in this blog post according to their class.
MDEL (Medical Device Establishment Licence)
The total price of MDEL varies between $12,000 and $19,000. The price is divided into three (3) major components: Health Canada’s application examination fees, application preparation fees, and classification confirmation fees.
An example of a small company is:
Any company, including its affiliates, with fewer than 100 workers OR with yearly gross revenues between $30,000 and $5 million (CAD).
Prior to submitting their application, applicants must be registered with Health Canada as a small company. Online registration is required for this event.
The price to prepare an MDEL application could vary from $6,750 to $11,250 depending on the class of your device, plus an additional fee of $900 to $2,250 to confirm the classification of the medical device.
MDL (Medical Device Licence):
For Class II, Class III, and Class IV medical devices, the total expense of MDL varies from $10,500 to $18,000, $38,000 to $43,000, and $10,500 to $38,000 respectively. The price is divided into four (4) major components: Health Canada’s application examination, right to sell, application preparation, and classification confirmation fees.
Manufacturers in Classes II, III, and IV are granted a Medical Device Licence (MDL) to allow the selling of medical devices in Canada. The categorization determines the costs for reviewing an MDL application. The following costs are accurate as of April 2022:
- $522 for Class II license applications and $10,679 for Class III license applications
- Class III license applications (near-patient), $20,723 Class IV license applications, $25,955
- Class II, III, or Class IV license applications (private label medical equipment), $152
- The cost for having the ability to market licensed Class II, III, or IV medical devices is $394.
As of April 1, 2020, small companies that meet the criteria will get:
- Their first-ever Pre-market Evaluation notification, application, or submittal is free, and all Pre-market Evaluation fees are reduced by 50%.
- 25% off all Right to Sell charges.
The price to prepare an MDL application could vary from $9,000 to $14,000, plus an additional fee of $900 to $2,250 to confirm the classification of the medical device.
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification.
