Health Canada Medical Device License Requirements

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Medical device licensing - Canada.ca

https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html

Access forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the listing database. ... Guidance documents for medical device licensing. ... Apply for a medical device licence. …

Guidance on how to complete the …

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

Overview. Medical devices are classified into one of 4 classes. Class I represents the lowest risk and Class IV represents the highest risk. Class II, III and IV medical …

Medical Devices Active Licence Listing (MDALL)

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

MDALL online query. MDALL online query is an HTML application used to search the MDALL. A search can be done by Company Name, Company ID, Licence Name, Licence …

Guidance on Medical Device Establishment Licensing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html

Medical devices - Canada.ca

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

Subscribe to medical device updates [2022-09-16] Health Canada's Action Plan on Medical Devices. Canadians rely on medical devices to maintain and improve …

Guidance on Medical Device Establishment …

About this document 1. Purpose. This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory …

Guidance on how to complete the application for a new …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence/implementation.html

Health Canada's Drug/Medical Device Combination Products Policy addresses the regulation of products that contain both a drug and medical device. IVDD test kits …

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

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

43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the Purposes of …

Obtaining a Health Canada Medical Device …

https://medicaldeviceacademy.com/health-canada-medical-device-license/

This article explains the process for obtaining a Health Canada Medical Device License through a hypothetical case study. Canadian Medical Device …

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