Health Canada Medical Establishment License

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Establishment Licences - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html

Health Canada guidance documents, policies, reports, directives, applications, forms, fee and export materials related to establishment licences for drugs, medical devices, pharmaceutical products and natural health products ... Frequently Ask …

Medical Device Establishment Licence (MDEL) …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

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

Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary. From Health Canada’s Regulatory Operations and Enforcement Branch. In light of COVID-19, …

Medical Devices Establishment Licence Listing - health …

https://health-products.canada.ca/mdel-leim/index-eng.jsp

The MDEL listing contains information about the licensed establishment including their company ID, licence number, company name, address, authorized activities and …

Medical Device Establishment Licences - Canada.ca

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-device.html

Medical Device Establishment Licences. Medical Devices Annual Review Documents. Application for a Manufacturer's Certificate to Cover Export of Medical …

Guidance on Medical Device …

This guidance document explains: Medical devices establishment licensing regime under sections 44 to 51.1 of the Medical Devices Regulations to the Food and Drugs Act. …

Frequently asked questions: Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html

Disclaimer. This document does not constitute part of the Food and Drugs Act or its regulations, and in the event of any inconsistency or conflict between the Act or regulations and this document, the …

Fees for Examination of an Application for an …

https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/medical-device-establishment-licence-funding-fees-drugs-health-products.html

Fee category. Fee as of April 1, 2022. Fee as of April 1, 2023. Medical Device Establishment Licence. $ 4,737. $5,060. Please visit Fees for Medical Devices for …

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

The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device …

Health Canada on Medical Device …

https://www.regdesk.co/health-canada-guidance-on-mdel-applications/

Health Canada on Medical Device Establishment Licensing. May 17, 2021. Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and …

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