Food and Drugs Act and the Medical Devices Regulations SOR/98-282

1. Key takeaways

The legal hierarchy for Canadian medical device registration is: the Food and Drugs Act provides the authorization, the Medical Devices Regulations (SOR/98-282) set out the obligations, and Health Canada guidance documents such as GUI-0016 give the operational interpretation. Guidance documents are not part of the Act or the Regulations, and where a guidance document conflicts with the Act or the Regulations, the Act and the Regulations prevail. Companies must therefore always cite the legal instruments and the guidance at their correct respective levels.

• The Food and Drugs Act sits at the top of the hierarchy and authorizes the making of the Medical Devices Regulations.
• SOR/98-282 is the operative regulation, current as of 2026-07-21 and most recently amended on 2026-06-17.
• GUI-0016 carries an explicit disclaimer that it forms no part of the Act or its regulations.
• Guidance documents such as GUI-0016 carry no force of law: they interpret the obligations operationally, but they are not part of the Act or the Regulations, and a reader must always be able to tell law from guidance at a glance.
• Fees are governed by a separate fee order, SOR/2019-124, and never by a provision of the Regulations themselves, so budget citations must name the fee order directly.

2. Legal basis

The table below lists the instruments relied upon in this article, with their provisions, dates, and official sources.

3. Expert insights

Insight one: the legal status of guidance documents is explicitly excluded from the law.

The disclaimer at the opening of GUI-0016, Version 11, states that the document forms no part of the Food and Drugs Act or its regulations, and that if any inconsistency or conflict arises between the document and the Act or the Regulations, the Act and the Regulations prevail. This is the direct textual basis for separating guidance from regulation when citing sources, and it is the reason this series always marks the level of every GUI document it references. Internal procedures should mirror this discipline so that a guidance citation is never mistaken for a legal requirement.

Insight two: the pace of amendment of the Regulations accelerated visibly in 2026.

The Medical Devices Regulations are current as of 2026-07-21 and were most recently amended on 2026-06-17, which is the publication date of SOR/2026-110. Companies planning their compliance work cannot rely on the 2024 version of the Regulations, or any earlier version, as their sole reference. Compliance plans, procedure documents, and training materials should be checked against the consolidated current text, and the currency date and the latest amendment date should be recorded so that anyone reviewing the file can confirm which version was used.

Insight three: the definition of “sell” includes leasing.

According to GUI-0016, the leasing of a device falls within the scope of the definition of sell in section 2 of the Food and Drugs Act. A company that leases or rents out medical devices is therefore subject to the Medical Devices Regulations in the same way as a seller, including the MDEL requirement of section 44. This point is frequently circumvented on the argument that the company only rents and never sells, but that argument does not hold up legally: the statutory definition already covers the arrangement, and the obligations follow the definition rather than the commercial label the parties attach to it.

Insight four: the basis for fees is a separate fee order, not the Regulations themselves.

Fees are set out in the Order Respecting the Fees for Licences for Drugs and Medical Devices (SOR/2019-124). Its Schedule 8 lists the medical device licence review fees, and its section 77 lists the annual fee for the right to sell. The two legal sources must be cited separately, and a fee must never be written into a provision of the Regulations as if the Regulations themselves set the amount. Budgeting documents and client submissions should carry both citations so that the basis of each fee can be traced to its own instrument. A review checklist that pairs each fee with its source also makes annual updates easier, because when either instrument changes, the paired citation flags the exact line that needs to be re-verified rather than the whole budget.

4. Practical recommendations

• Fix the citation order as follows: the Act, then the Regulations, then the Canada Gazette registration documents, then guidance, then consensus standards, then industry compilations.
• Whenever a GUI document is cited, state at the same time that guidance is an administrative document and that the Regulations prevail in case of conflict.
• Each year, check the current-as-of date and the most-recently-amended date of the Medical Devices Regulations and confirm which consolidated version is in use.
• Treat leasing businesses as sales and configure the MDEL and the related procedure documents accordingly.
• Cross-check all fee references against both SOR/2019-124 and the Health Canada fees page before they enter a budget or a client deliverable.

5. Verification checklist

• □ The citation hierarchy order has been confirmed, and guidance has not been cited as if it were regulation
• □ The current version date of the Medical Devices Regulations has been checked (2026-07-21)
• □ It has been confirmed that leasing business is treated as a sale
• □ Fee references have been checked against SOR/2019-124 and the Health Canada fees page
• □ The coming-into-force date of SOR/2026-110 (2026-12-14) has been recorded
• □ Expired version references have been removed from the internal document list

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