![]() There are no regulatory quality system requirements for Class I medical devices. ![]() ![]() 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. The Medical Devices Regulations do not require importers or distributors of medical devices to have a registered quality system. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars. Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement.
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