How to Apply for a Medical Device Establishment Licence Using Form FRM-0292

1. Key takeaways

The application for an establishment licence (MDEL) is made using form FRM-0292. Under section 45 of the Medical Devices Regulations, the application must provide establishment and contact information, device classes and manufacturer information, among other items; MDEL holders must also undergo an annual licence review under section 46.1. A prerequisite for obtaining an MDEL is the establishment of written procedures demonstrating the ability to respond to complaints and to conduct recalls when required.

• The application form is FRM-0292, and the information to be provided is set out in section 45 of the Medical Devices Regulations.
• Section 45 was amended by SOR/2026-110, with the amendment taking effect on December 14, 2026, so the application checklist has changed in structure.
• Written procedures covering complaint handling, recalls and mandatory problem reporting are the substantive threshold for obtaining an MDEL.
• The MDEL fee is CAD 5,519 as of April 1, 2026, and applies equally to foreign and domestic establishments across three fee scenarios.
• Guidance on the full process is found in GUI-0016, version 11, which is aligned with the amended regulations.

2. Legal basis

The requirements for the MDEL application come from several official sources, each of which was verified when this guide was prepared. The table below summarises the relevant instruments, the provisions involved, the key dates and the official source of each item.

Taken together, these sources show that the application is not a single-form exercise: the information required by the amended section 45, the written procedures expected by Health Canada, and the fee that accompanies the application all have to be in place before an establishment licence can be granted.

3. Expert insights

Insight 1: the threshold for an MDEL is written procedures, not premises.

The official Health Canada wording is: “To receive an MDEL, companies must have established written procedures to demonstrate they can respond to complaints and conduct recalls if required.” Manufacturers and importers must additionally have procedures for reporting recalls and serious device problems to Health Canada. In practice this means the review of an application focuses on whether the company can actually demonstrate a functioning post-market system on paper, rather than on the physical footprint of the business. A company should be able to show, document by document, how a complaint would be received, assessed and answered, and how a recall would be initiated, executed and closed.

Insight 2: the scope of the procedure requirements widens after December 14, 2026.

Under SOR/2026-110, paragraph 45(j) is replaced with a requirement to provide “the address of every building at which the procedures described in sections 52, 58 and 58.1, paragraphs 59(3)(4) and section 61.2(4) are located”. This ties the application information directly to the premises where the documented procedures actually operate, instead of relying on a general declaration. Companies can no longer describe their procedure framework in abstract terms; they must be able to point to specific buildings where each required procedure is maintained and put into practice, and the addresses listed must match reality.

Insight 3: paragraphs 45(e) and 45(g) to (i) are repealed.

Under item 2 of SOR/2026-110, paragraph 45(e) is repealed (it formerly dealt with information relating to medical specialties), and paragraphs 45(g) to (i) are repealed. The application checklist has therefore been restructured, and the logic used to complete the old version of the form can no longer be carried over. Anyone preparing an application from an older template risks submitting information that is no longer required while omitting new items such as supplier information. Working from the current form and the current version of the guidance is the only reliable approach.

Insight 4: the MDEL fee is the same inside and outside Canada, and covers three scenarios.

The Health Canada fees page states that fees are charged for a first MDEL, for a subsequent annual licence and for reinstatement of an MDEL, and that these fees “are applied equally to foreign and domestic establishments”. The amount is CAD 5,519 as of April 1, 2026. Budgeting should therefore treat the MDEL as a recurring annual cost rather than a one-off payment, and foreign applicants should not expect any rate difference based on where they are established.

4. Practical recommendations

• Complete the three sets of written procedures before submitting the application: complaint response, recall conduct and mandatory problem reporting.
• Prepare the application information item by item against the amended section 45, and do not reuse the old checklist.
• List the address of every building as required by amended paragraph 45(j), and make sure the list matches where the procedures are actually kept.
• Budget on the basis of CAD 5,519, covering all three fee scenarios: first application, annual licence and reinstatement.
• Use the current version of form FRM-0292, aligned with the wording of GUI-0016 version 11.

5. Verification checklist

• □ Written procedures for complaint response, recall conduct and mandatory problem reporting are established
• □ Application information is prepared item by item against the amended section 45
• □ The address of every building under paragraph 45(j) is listed and matches actual practice
• □ It is confirmed that paragraphs 45(e) and 45(g) to (i) are repealed and the old checklist is not reused
• □ The budget covers the three fee scenarios at CAD 5,519
• □ The current version of FRM-0292 is used

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Canadian market. Our team manages Health Canada Medical Device Licence and MDEL applications, prepares risk-classified dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com