The costs and time required for processing a Class II in vitro diagnostic (IVD) medical device Medical Device License (MDL) registration in Canada depend on the application fees and the review timelines established by Health Canada. Here’s a breakdown of both:

1. Costs

The fees for an MDL application are set by Health Canada and are subject to updates. Below are the main cost considerations:

• Application Fee for Class II MDL: The application fee for a Class II MDL is typically less than for higher-risk Class III and IV devices. As of recent guidance, Class II application fees are around CAD $5,000 to CAD $6,000, but these can vary.
• Fee Reductions: Some applicants, such as small businesses, may be eligible for a reduced fee. Health Canada offers a 25% fee reduction for companies that qualify as small businesses (those with gross revenues of CAD $100,000 or less).
• Annual License Renewal Fees: Once the MDL is approved, Health Canada requires an annual license renewal fee for continued market authorization, typically around CAD $350 for Class II devices.

2. Time Required

The time required to process a Class II MDL application involves several stages, including application submission, initial review, and technical assessment by Health Canada:

• Review Time for Class II MDL: Health Canada’s target review timeline for Class II MDL applications is approximately 60 calendar days from the date of a complete submission. However, if there are deficiencies or requests for additional information, the review time may extend.
• Preparation Time: Applicants should allow several weeks to a few months to prepare the submission, including gathering evidence, completing documentation, and ensuring QMS compliance.
• Response to Requests for Additional Information: If Health Canada requests additional information or clarification, promptly addressing these requests will minimize potential delays in the review process.

3. Additional Considerations

• MDSAP Audits: For Class II devices, manufacturers are required to maintain ISO 13485 certification under the Medical Device Single Audit Program (MDSAP). The audit costs vary by the auditing organization but can be in the range of CAD $15,000–$30,000 annually.
• Post-Market Compliance Costs: After the MDL is approved, there may be ongoing costs related to post-market surveillance, adverse event reporting, and compliance audits.

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