Health Canada Medical Device Regulations Section 59

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

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

59 - Incident Reporting; 61.2 - Serious Risk of Injury to Human Health; 61.4 - Summary Report; 62 - Provision of Information Under Section 21.8 of Act; 62.1 - Assessments Ordered Under Section 21.31 of the Act; 62.2 - Activities Ordered Under …

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

An incident report is required under section 59(1.1) of the Regulations for any incident, involving a Class I medical device, occurring outside Canada (foreign …

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

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

Medical Devices Regulations - laws-lois.justice.gc.ca

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-4.html

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 …

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, …

Canada Gazette, Part 2, Volume 154, Number 26: …

https://www.gazette.gc.ca/rp-pr/p2/2020/2020-12-23/html/sor-dors262-eng.html

59 (1) The manufacturer and the importer of a medical device shall each make a preliminary and a final report to the Minister concerning any incident that comes …

Medical Devices Regulations

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-9.html

(a) it is intended to be used to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening disease if there is a risk of propagation in the …

Medical Devices Regulations - laws-lois.justice.gc.ca

https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/page-7.html

(a) the name of the device, its control number and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, …

Mandatory Medical Device Problem Reporting Form for …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-medical-device-problem-reporting-form-industry-adverse-reaction-reporting.html

In the context of mandatory problem reporting, information on the incident refers to the circumstances requiring reporting under section 59 of the Medical Devices Regulations. …