Changes To Canadian Medical Device Regulations

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

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

Medical Devices Regulations. 1 - Interpretation; 2 - Application; 6 - Classification of Medical Devices; 8 - PART 1 - General. 8 - Application; 9 - Manufacturer’s Obligations; 10 - Safety and Effectiveness Requirements; 21 - …

Regulations amending certain regulations concerning …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/notice-amending-regulations-drugs-medical-devices-shortages.html

What's new: Medical devices - Canada.ca

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

Medical Devices Licence Amendment Fax-Back Form - Guidance for Changes to the Manufacturer's Name And / Or Address Of Existing Device Licences Only [2020-04-30] …

Recent Changes to Medical Device …

https://www.regdesk.co/summary-recent-changes-to-medical-device-regulations-in-canada/

Jul 15, 2021. In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this …

Medical devices - Canada.ca

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

The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis …

Notice: New regulations strengthening the post-market …

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/post-market-surveillance-medical-device-regulations-notice.html

Health Canada is making regulatory changes to the Medical Devices Regulations to strengthen the lifecycle approach to the regulation of medical devices by increasing post …

Foreign Risk Notification, Annual Summary Reports, and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/medical-devices/proposed-amendment-medical-device-regulations/document.html

Health Canada is proposing regulatory changes to the Medical Devices Regulations (MDR) in order to strengthen the lifecycle approach to the regulation of medical devices …

Guidance documents – Medical devices - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

Guidance for the Interpretation of Significant Change of a …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-interpretation-significant-change-medical-device.html

The concept of significant change is linked to the principles of safety and effectiveness and the ability of a risk-based regulatory system to control the risk of …

Consultation on Changes to Canadian Medical Device …

https://www.regdesk.co/consultation-on-changes-to-canadian-medical-device-regulations/

Health Canada, the country’s regulating authority in the sphere of healthcare products, has announced a consultation for proposed amendments to the Medical …

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