Health Canada Medical Device Regulations Section 36

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

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

36 - Issuance 37 - Lot of In Vitro Diagnostic Devices 38 - Refusal to Issue 39 - Requests by Minister 40 - Suspension 43 - Obligation to Inform 43.1 - Obligation to Submit Certificate 43.11 - Disclosure of Information in Respect of Clinical Studies or …

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

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

Draft Health Canada IMDRF table of contents for medical …

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

3.2.1 Licence applications and Section 36 and 39 responses. All Medical Device Licensing related interactions including responses to Letters issued under Section 36 or 39 of the Medical Device Regulations should be …

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 Regulations - laws-lois.justice.gc.ca

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

36 (1) If the Minister determines that a medical device in respect of which an application is submitted meets the applicable requirements of sections 10 to 20, the Minister shall (a) …

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, …

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 …

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

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

Disclosure of Information in Respect of Clinical Studies or Investigational Testing (continued) 43.12 (1) Information in respect of a clinical study or investigational testing …

Guidance for the Interpretation of Sections 28 to 31: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-interpretation-sections-28-31-licence-application-type.html

For more information on the interpretation of sections 28 to 31 of the Medical Devices Regulations please contact: Medical Devices Bureau Therapeutic Products …