Health Canada Medical Device Definition

The Canadian federal agency that oversees and regulates the Canadian Institutes of Health Research the pricing and safety of patent medicines marketed in Canada the safety of Canadian health and food products the health care provided to First Nations and Inuit peoples and the Canadian Public Health Agency. The term Software as a Medical Device is defined as software intended to be used for one or more medical purposes as defined in the regulations.

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Health Canada will generally consider software as having a medical purpose where it is intended to.

Health canada medical device definition. The present revision is intended to reflect the changes to the definition of medical device made to the Food and Drugs Act the Act following the enactment of the Protecting Canadians from Unsafe Drugs Act Vanessas Law on November 6 2014 and to bring greater clarity to the description of how Health Canada classifies health Footnote 1 products at the device-drug interface. It regulates the use of consumer goods drugs biologics medical devices and natural health products. Medical purposes are set out in the definition of device in the Act.

Active diagnostic devicemeans an active device that whether used alone or in combination with another medical device is intended to supply information for the purpose of detecting monitoring or treating a physiological condition state of health illness or congenital deformity. Health Canada considers that software is a medical device when. Health Canada is a federal department responsible for the national public health of Canadians.

Additional information on how medical devices are approved and authorized in Canada is available on the fact sheet Safe Medical Devices in Canada. Only Class I devices require an establishment license. An in vitro diagnostic device or IVDD means a medical device or a product subject to section 3 of the Medical Devices Regulations that is to be used in vitro for the examination of specimens derived from the human body.

The approval sale marketing safety and quality of medical devices in Canada is regulated by The Medical Devices Bureau of the Therapeutic Products Directorate TPD. This definition includes software that is imbedded or permanently a part of a medical device software that is an accessory to a medical device or software that is itself a medical device. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device.

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. It is intended to be used for one or more medical purposes as outlined in the definition of device in the Act and. Health Canada is the Federal department responsible for reviewing medical devices and in vitro diagnostic devices IVD devices to assess their safety effectiveness and quality before being authorised for sale in Canada.

A device means an instrument apparatus contrivance or other similar article or an in vitro reagent including a component part or accessory of any of them that is manufactured sold or represented for use in a diagnosing treating mitigating or preventing a disease disorder or abnormal physical state or any of their symptoms in human beings or animals b restoring modifying or correcting the body. Class I IIa IIb and III are the European classifications while Class I II III and IV are the Canadian classifications. Means a medical device that is identical in every respect to a medical device manufactured by an original manufacturer and licensed by Health Canada except that the device is labelled with the private label manufacturers name address and product name and identifier.

Within Health Canada the Health Products and Food Branchs mandate is to take an integrated approach to minimising the health risk factors to Canadians while maximising the safety provided by the regulatory system for health. Therefore your company will be able to sell directly to physicians prescribing your device if you have a Class II III or IV Medical Device License. Accessory for a medical device means an article which whilst not being itself a medical device is intended by its manufacturer to be used together with one or several particular medical device s to specifically enable the medical device s to be used in accordance with itstheir intended purpose s or to specifically and directly assist the medical functionality of the medical device.

The set of instructions used to control the actions or output of a medical device to provide input to or output from a medical device or to provide the actions of a medical device. Acquire process or analyze a medical image or a signal from an in vitro diagnostic device or a patternsignal from a signal acquisition system or imaging device. A Canadian Medical Device License is a license to distribute medical devices.

The Canadian classification rules are located on pages 54-57 of the Canadian Medical Device Regulations httpbitlyFindCMDR. There are four European and Canadian medical device classifications.

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