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This document outlines the strategy and provides guidance for the medical device industry on Health Canada's compliance and enforcement activities.
…This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements …
Canada's Access to Medicines Regime provides a way for the world's developing and least-developed countries to import high-quality drugs and …
The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, …
The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or …
These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging …
We are updating how we disclose the clinical information used to assess the safety and effectiveness of drugs and medical …
Drug and medical device manufacturers submit clinical information to Health Canada for the approval of new products. Health Canada assesses …
Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food …
These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply …