Canadian Medical Device Regulations Part 1

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 - Labelling Requirements; 24 …

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

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

Medical Devices Regulations

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

Rule 1: (1) Subject to subrules (2) and (3), all surgically invasive devices are classified as Class II. (2) A surgically invasive device that is intended to diagnose, …

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

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

PART 1 General Application 8 This Part applies to medical devices that are not subject to Part 2 or 3. Manufacturer’s Obligations 9 (1) A manufacturer shall ensure …

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

The Activities section contains information supporting Health Canada's regulation of medical devices, including announcements, consultations and fact sheets …

Guidance Document: Guidance for the Labelling of …

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

Section 21 (1) (i) - The directions for use, unless directions for use are not required, (i) in the case of decorative contact lenses, for the device to be used safely, and …

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 requirement for device licensing (DL) or authorization (sections 26, 70 or 80), the requirement for establishment licensing (EL) (section 44), stop sale for class I …

Canada Gazette Part I - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/legislation-guidelines/canada-gazette-part1.html

Canada Gazette Part I The following proposed regulatory amendments and Regulatory Impact Analysis Statement (RIAS) were recently pre-published in the Canada …