Health Canada

Canada's Access to Medicines Regime provides a way for the world's developing and least-developed countries to import high-quality drugs and medical devices at a lower cost to treat the diseases that bring suffering to their citizens.

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada.

The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. This guide provides information on how medical devices are approved and authorized in Canada.

These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging sponsors in their research activities for new therapies.

We are updating how we disclose the clinical information used to assess the safety and effectiveness of drugs and medical devices.

Drug and medical device manufacturers submit clinical information to Health Canada for the approval of new products. Health Canada assesses this clinical information to reach a decision on whether or not to approve a drug or medical device.

Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food and Drug Regulations. Also in accordance with the Food and Drug Regulations, a manufacturer of a drug must annually, before October 1, notify Health Canada that the drug is still on the market and...

These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply with regulations, specifically drug establishment licence (DEL) requirements in Part C, Division 1A of the FDR.

Health Canada's drug products fact sheet describes how drugs are reviewed in Canada including how drugs are developed and submitted for authorization to conduct clinical trial.

How to access a list of generic drug submissions currently under review.

For eligible submissions accepted into review on or after October 1, 2018, the submission 'class' added to the Lists of submissions currently under review.

Present the list of new drug submissions (NDSs) that are currently being reviewed.

Understand the decisions to approve or not approve the sale of drugs and medical devices in Canada.

Drug shortages can occur for any number of reasons and can result from problems at any point in the drug supply chain.

The Canadian drug supply chain is complex, with distinct roles and responsibilities among many players including manufacturers, wholesalers, hospitals, health care practitioners and governments. Drug shortages can occur at any point in the drug supply chain.

This notice explains under which circumstances non-medical masks or face coverings would be subject to the regulatory framework for medical devices during the COVID-19 pandemic.

All Canadian drug establishments must have a drug establishment licence to fabricate, package/label, distribute, import, wholesale or test a drug as required under Part C, Division 1A of the Food and Drug Regulations.

Good manufacturing practices (GMP) ensure that drugs meet the quality standards appropriate to their intended use before they are sold.

Health Canada is warning Canadians about the risks of purchasing health products that make unauthorized claims to prevent, treat or cure COVID-19.

Health Canada introduced innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards.