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

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....

Health Canada has successfully completed the transition to the Medical Device Single Audit Program (MDSAP). All manufacturers holding medical device licences in Canada now...

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...

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...

Responding to the Opioid Crisis and Other Emergency Situations.

The purpose of this document is to recommend international standards for, and promote harmonisation of, the nonclinical safety studies recommended to support human clinical...

Listing of therapeutic products with paediatric information available in their labelling

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...

List of Recognized Standards for Medical Devices

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...

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

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...

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.

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...

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....

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...

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.

Through its Action Plan on Medical Devices, Health Canada is committed to continuing to provide Canadians with more information on the medical devices they use. The Department...

This guidance document is specific to the "tamper-resistance" feature of controlled-release opioid products. It is intended for the pre-market review of drug submissions when...