New Health Canada Guidance for Custom-Made Medical Devices

Overview

Food and Drug Law
Food and Drug Regulatory LawHealth Canada has now released a guidance document to better inform manufacturers and health care professionals of the requirements and authorized activities pertaining to custom-made medical devices.

As per the Canadian Medical Device Regulations, a custom-made device is a medical device that is not mass-produced and that is manufactured in accordance with a health care professional’s written direction of its design characteristics. It differs from medical devices generally available for sale or from a dispenser and it is manufactured for the sole use of a particular patient of that professionals, or is for use by that professional to meet special needs arising in the course of his or her practice.

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