Canada Update: Proposed Amendments to Regulations on Licensing Drugs and Medical Devices

Health Canada is proposing amendments to regulations on licensing drugs and medical devices. Also, Health Canada published its annual adjustment of fees for the fiscal year 2023-2024. In other news, Health Canada announced the interim enforcement approach for COVID-19 testing initiatives is extended until December 31, 2023.

Proposed amendments to regulations and guidances on licensing drugs and medical devices

Health Canada is proposing amendments to Subsections 36(2-4) and Section 37 of the Medical Devices Regulations and certain provisions of the Food and Drug Regulations to increase regulatory agility in licensing drugs and medical devices, keep pace with innovation, and facilitate access to advanced treatments and therapies. The proposed amendments specific to medical devices would expand the scope of the terms and conditions (T&Cs) for Class II, III, or IV medical device licenses beyond testing requirements, where T&Cs can be imposed or amended at licensing or after licensing.

Annual adjustment of fees for the fiscal year 2023-2024

The Department of Health published the annual adjustment of fees for medical devices effective April 1, 2023. The fees for Fiscal Year 2023-2024 are subject to a 6.8% Consumer Price Index which resulted in higher fees for establishment license and medical device license applications.

Interim enforcement approach for COVID-19 testing initiatives pushed to December 2023

Health Canada announced that the interim enforcement approach for implementing federal, provincial, and territorial COVID-19 testing initiatives is extended until December 31, 2023. Under this enforcement approach, participating establishments are not required to hold a Medical Device Establishment License (MDEL) when distributing COVID-19 tests under the terms and conditions of a federal, provincial, or territorial COVID-19 testing initiative. The enforcement policy also provides the conditions which would allow marketing or advertising of COVID-19 tests with claims different from their market authorization (“off-label”).