Health Canada Medical Device Establishment Registration

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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

If you sell or import any class of medical devices in Canada, you must apply for and maintain a Medical Device Establishment Licence (MDEL), unless you meet exemption(s) in section 44 of the Medical Devices Regulations. You must use this form to apply for an MDEL. Use this application form to: 1. apply for an … See more

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 - Canada.ca Medical Device Establishment Licences Medical Devices Annual Review Documents Application for a …

Establishment Licences - Canada.ca

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

Guidance to apply for a Manufacturer's Certificate to Export licenced medical devices from Canada (GUI-0097) Inspections; Medical Device Establishment …

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 …

Licence, authorization and registration forms for drug …

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

Licence, authorization and registration forms for drug and health products. Guidance documents for drug, medical device, natural health product and site licensing. Also find …

Fees for Medical Devices - Canada.ca

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

Medical devices establishment licence fees. A Medical Device Establishment Licence (MDEL) is issued for activities of importing or distributing …

Medical device application and report forms - Canada.ca

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

Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) [2020-04-01] Medical Devices Licence Amendment Fax-Back Form - …

Frequently asked questions: Medical device …

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

If the Medical Device Establishment Licence (MDEL) fees have not been paid, Health Canada has the authority to withhold services, approvals, rights and/or privileges. …

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

Health Canada is the federal regulator of therapeutic products, including medical devices. We do not provide medical advice on the use of the products identified in this listing. The …

Health Canada CMDR Medical Device Registration and Approval

https://www.emergobyul.com/services/canadian-cmdr-consulting-health-canada-medical-device-registration

Health Canada medical device licensing In Canada, you are required to obtain a Medical Device Establishment License (MDEL) if you intend to market your Class I device, or a …

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