The cost of MDL (Medical Device License) certification varies depending on the type and complexity of the medical device, as well as the scope of documentation required. In addition, Health Canada may have different fee policies depending on the circumstances. As a result, it is not possible to provide exact cost figures.
In general, the cost of MDL certification usually includes the following:
Application Fee: This is the fee to be paid when submitting an application for MDL certification. The amount of the fee may vary depending on the type of medical device being requested.
Audit fee: The Ministry of Health may review and evaluate the submitted documents and may ask for payment of the audit fee. The exact amount of the audit fee may vary depending on the complexity of the medical device and the workload of the review.
Annual Maintenance Fee: Once an MDL is obtained, there is usually an annual maintenance fee to maintain the validity of the license. These fees may vary depending on the type of MDL and the volume of medical device sold.
As a result, the total cost of MDL certification depends on several factors and can vary on a case-by-case basis. It is advisable to contact Health Canada or a certification body for details on the specific costs and requirements for MDL certification. Alternatively, consider consulting with a professional medical device registration consulting firm for more information on fees and processes.