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11 kwi 2002 · Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices. ISO 17664-2:2021-Ed.1.0.
Medical Devices Regulations (SOR /98-282) Regulations are current to 2024-10-14 and last amended on 2024-01-03. Previous Versions. Enabling Act: FOOD AND DRUGS ACT.
18 sty 2010 · The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices.
Links to acts and regulations, guidance documents and policies related to medical devices from Health Canada
custom-made device means a medical device, other than a mass-produced medical device, that. (a) is manufactured in accordance with a health care professional’s written direction giving its design characteristics; (b) differs from medical devices generally available for sale or from a dispenser; and. (c) is.
22 lis 2024 · ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Health Canada's website has a section for medical device regulations: Acts and Regulations; Guidance Documents; Medical Devices Active Licence Listing (MDALL)
