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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 - …
Medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
- Medical devices. 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, …
Legislation and Guidelines - Medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines.html
- The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to …
Frequently Asked Questions - Medical Devices Regulations
- https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/frequently-asked-questions-medical-devices-regulations.html
- There are several types of applications for authorization under the Medical Devices Regulations: Class II medical device licence; Class III medical device licence; Class IV …
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 …
About medical devices - Canada.ca
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/about-medical-devices.html
- In Canada, medical devices are grouped into 4 classes based on the expected level of risk to a person's health and safety. Class I medical devices (e.g., a thermometer) pose the …
Medical Devices Regulations ( SOR /98-282) - laws …
- https://laws-lois.justice.gc.ca/eng/regulations/SOR%2D98%2D282/FullText.html
- (a) the sale and advertising for sale of a medical device; and (b) the importation of a medical device for sale or for use on individuals, other than importation for personal use. …
Incident reporting for medical devices: …
- https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html
- Since Health Canada and its regulatory partners have similar reporting requirements, the Regulations enable Health Canada's participation in international alert …
Foreign Risk Notification (Sections 61.2 and 61.3)
- 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 …
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