Medical Devices

On August 18, 2025, the U.S. Department of Commerce expanded tariffs on steel and aluminum derivatives.  They added 407 new product categories that are subject to a 50% tariff rate on their metal [...]

Health Canada has released a new guidance document outlining the use of Terms and Conditions (T&Cs) for Class II, III, and IV medical devices. Set to take effect on January 1, 2026, this [...]

In a significant regulatory update, Health Canada’s Pest Management Regulatory Agency (PMRA) has announced its intention to exempt antimicrobial-treated Class I medical devices from the Pest [...]

Regulatory Framework  Overview of FDA and Health Canada Regulations  The Food and Drug Administration (FDA) and Health Canada are regulatory agencies responsible for ensuring the efficacy and [...]

As part of its Forward Regulatory Plan (2024-2026), Health Canada is modernizing the Medical Device Establishment Licensing (MDEL) framework. This modernization effort aims to enhance regulatory [...]

By: By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email Introduction In Canada, the intended use of a medical device primarily determines its class. Classification must be consistent with the [...]

By: By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email Introduction to Medical Devices in Canada Medical devices are defined in the Food and Drugs Act as health or medical instruments used for [...]

By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email   What is Medical Device Quality Assurance? Medical devices in Canada encompass a broad spectrum of instruments utilized in the [...]

By: Ivy Tang, PRINCIPAL REGULATORY CONSULTANT, email In the realm of medical device safety, effectiveness, and quality, Canada has some of the strictest regulatory requirements. One of the key [...]

By: Jan Noupbaev, ASSOCIATE DELL TECH LABORATORIES Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product [...]