Canadian Medical Device Regulations Sor 98 282

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/

Medical Devices Regulations ( SOR /98-282) Full Document: HTML (Accessibility Buttons available) | XML [299 KB] | PDF [649 KB] Regulations are current to 2022-12-31 and last amended on 2022-09-27. Previous Versions Enabling Act: FOOD …

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR%2D98%2D282/FullText.html

Medical Devices Regulations ( SOR /98-282)

https://laws.justice.gc.ca/eng/regulations/SOR-98-282/page-3.html

32.1 The Minister shall recognize a person as a registrar for the purpose of issuing, renewing, suspending or cancelling quality management system …

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/section-sched1022099.html

Any other active device is classified as Class I. Special Rules Rule 13: A medical device that is intended to be used for (a) disinfecting or sterilizing blood, tissues …

Medical Devices Regulations ( SOR /98-282) - laws …

https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/page-2.html

(a) the name of the device; (b) the name and address of the manufacturer; (c) the identifier of the device, including the identifier of any medical device that is part of a system, test …

Legislation and Guidelines - Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines.html

Acts and Regulations The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food …

SOR/98-282 | Medical Devices Regulations (Canada)

https://www.document-center.com/standards/show/SOR/98-282

The Canadian Medical Devices Regulations (SOR/98-282) apply to the manufacturing, sale, advertising for sale, and importation of medical devices, including in vitro …

Health Canada CMDR Updates 2021 – ComplianceAcuity

https://www.complianceacuity.com/health-canada-cmdr-updates-2021/

The SOR/98-282 changes that took effect on 23 June 2021 are expected to be incorporated into the Justice Laws website version within a couple weeks. The SOR/98-282 changes …

Guidance on Medical Device Compliance and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-medical-device-compliance-enforcement-0073.html

The purpose of this document is to provide the medical device industry with a clear description of compliance and enforcement actions relating to the Medical Devices …