According to the Health Canada,” is pleased to announce that it is currently developing a draft guidance document to assist medical device manufacturers seeking to license 3D-printed devices.
Increasingly, 3D printing (or additive manufacturing) has brought new innovations in medical devices for healthcare professionals and patients and has become integral to healthcare systems. Hospitals, which manufacture 3D-printed implantable medical devices for distribution beyond their institution, qualify as a manufacturer and have to comply with the same regulatory obligations as other medical device manufacturers”.
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