The cost to obtain an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada depends on the medical device’s classification. In this blog, we will break down the costs for both MDELs and MDLs based on their class.

MDEL (Medical Device Establishment Licence)

The overall cost for MDEL ranges from $12,000 to $19,000. The cost is broken down into three (3) main parts: fees charged by Health Canada for application examination, fees for application preparation, and fees for classification confirmation.

A Medical Device Establishment Licence (MDEL) is a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in Canada. As of April 2022, the fee for the examination of an MDEL application is $4,737. However, Applicants who meet the criteria of a small business will be eligible for a 25% reduction of the fee payable.

A small business is defined as:

• any business, including its affiliates, that has fewer than 100 employees OR
• has between $30,000 and $5 million (CAD) in annual gross revenues

Applicants must be registered as a small business with Health Canada before submitting their application. This registration must be completed online.

Depending on your device’s class, the cost to prepare an MDEL application could range from $6,750 to $11,250, plus an additional fee of $900-$2,250 to confirm the medical device’s classification.

MDL (Medical Device Licence)

The overall cost for MDL ranges from $10,500 to $18,000 for Class II, $10,500 to $38,000 for Class III and $10,500 to $43,000 for Class IV medical devices. The cost is broken down into four (4) main parts: fees charged by Health Canada for application examination, fees for the right to sell, fees for application preparation, and fees for classification confirmation.

A Medical Device Licence (MDL) is a licence issued to Class II, III, and IV manufacturers to permit the sale of a medical device in Canada. The fees for the examination of an MDL application depend on the classification. These fees listed below are as of April 2022:

• Applications for Class II licence, $522
• Applications for Class III licence, $10,679
• Applications for Class III licence (near-patient), $20,723
• Applications for Class IV licence, $25,955
• Applications for Class II, III or Class IV licence (private label medical device), $152

In addition, there is a $394 fee for the right to sell licensed Class II, III or IV medical devices.
As of April 1, 2020, qualifying small businesses will receive:

• Their first ever Pre-market Evaluation submission / application / notification for free
• 50% reduction for all Pre-market Evaluation fees
• 25% reduction for all Right to Sell fees

Depending on the device classes, the cost to prepare an MDL application could range from $9,000 to $14,000, plus an additional $900-$2,250 fee to confirm the medical device’s classification.

Should require assistance with an MDEL and/or MDL application or have questions about your medical device, please contact us today.