Health Canada Medical Device Classification
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Medical device classification in canada.
Health canada medical device classification. 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. Draft health canada imdrf table of contents for medical device applications guidance 2019 02 28 implementation of advance notice of importation process for medical devices 2019 02 12 guidance on advance notice of importation under section 21 1 of the medical devices regulations mdr and section 3 1 of the radiation emitting devices. The medical devices regulations in canada are established by the government of canada and regulated by health canada.
Health canada licenses all class ii iii and iv medical devices imported advertised and sold in canada. The safety and effectiveness evidence required to support a medical device licence application is proportional to the risk of the device which is determined by applying the classification rules for medical devices detailed in schedule 1 of the regulations. The medical devices regulations regulations utilize a risk based approach to regulating products within its scope.
The medical devices regulations regulations utilize a risk based approach to regulating products within its scope. Before medical device and in vitro diagnostic ivd device manufacturers can legally sell their products in canada they must comply with health canada s medical device regulations. The device classification for canada must be based on the risk based classification approach specified by health canada.
Health canada holds the medical device manufacturers importers and distributors as accountable to correctly classify their medical devices as per health canada regulations. Additional information on how medical devices are approved and authorized in canada is available on the fact sheet safe medical devices in canada. The safety and effectiveness evidence required to support a medical device licence application for an in vitro diagnostic device ivdd is proportional to the risk of the device which is determined by applying the classification rules detailed in part ii of schedule 1 of the.
Similar to the. Before issuing a licence we verify that the device meets the requirements for safety and effectiveness and complies with the standards for a quality management system. Class ii iii or iv medical devices cannot be sold or imported in canada without a valid medical device licence mdl.
And eu to sell into the canadian marketplace you must first determine the medical device classification under canada s regulation.
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