Health Canada

Through the special access program (SAP) for medical devices, health care professionals can access custom-made and unlicensed medical devices for patients under their care.

While hyperbaric oxygen therapy is recognized as an effective treatment for 14 specific conditions listed below, the operators of some private clinics claim it can also be used to treat such conditions as multiple sclerosis, cerebral palsy, cancer, AIDS, stroke and migraine headaches. There is no...

This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH.

Animal-sourced insulins and biosynthetic (man-made) human insulins are used worldwide for managing diabetes. Recently, some concern has been expressed about the overall safety of insulins and the availability of animal-sourced insulins for those patients who cannot manage their disease using...

An insulin pump is a medical device used by people with diabetes. It's an alternative to multiple daily injections of insulin using a syringe or pen.

This labelling standard applies to ethylene oxide products labelled for use as gaseous sporicides in sterilizing medical instruments/devices. It does not apply to any other liquid and gaseous drug products to be used in sterilizing procedures and equipments for medical instruments/devices.

Overview of submission and regulatory requirements for licensing a medical device in Canada.

The List of Drugs for an Urgent Public Health Need (the List) contains the following drug-related details: the brand name, the medicinal ingredient(s), the route of administration, the strength, the dosage form and the identifying code or number, if any, assigned in the country in which the drug...

List of Recognized Standards for Medical Devices

This list represents substances and formulations which have been assessed by the Therapeutic Products Directorate on the basis of an application to market or further to promotion of products for medicinal purposes where safety and efficacy for such purposes have not been established.

Listing of therapeutic products with paediatric information available in their labelling

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals.

Responding to the Opioid Crisis and Other Emergency Situations.

Medical batteries are medical devices and are regulated under the Food and Drugs Act and Medical Devices Regulations. The Act and Regulations govern the import, advertising and sale of medical devices in Canada.

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device licences in Canada now participate in the program, which improves Health Canada's oversight of the medical devices sold in Canada, and ensures that...

A growing number of Canadians are using medical test kits in their homes to diagnose or monitor certain health conditions. These test kits are considered to be medical devices. Like all medical devices, they provide potential benefits, but they can also present risks.

This guidance document provides medical device stakeholders with information on the requirements that the Therapeutics Products Directorate will use in recognizing Auditing Organizations under the MDSAP.

This guidance document applies to drugs regulated under Part C, Division 1 of the Regulations that have received a DIN pursuant to Section C.01.014.2. This includes pharmaceuticals for human and veterinary use, as well as disinfectant drugs, but excludes biologics and radiopharmaceuticals and any...

This report, which is tabled under section 20 of the Service Fees Act and section 4.2.8 of the Directive on Charging and Special Financial Authorities, contains information about the fees that Health Canada had the authority to charge in the 2022-23 fiscal year.