Medical Device Establishment Licence Fees

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

Fee. FY 2023. $6,493. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those...

Medical Device User Fee Amendments (MDUFA) | FDA

https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

Medical Device User Fee Amendments (MDUFA) User Fees for FY2023 Annual Establishment Registration Fee: $6,493 All establishments must pay the …

Medical Device User Fee Rates for Fiscal Year 2022

https://www.federalregister.gov/documents/2021/08/02/2021-16408/medical-device-user-fee-rates-for-fiscal-year-2022

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 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 relevant guidance …

Fees for Medical Devices - Canada.ca

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

Medical devices licence fees. The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types …

Fees for the Review of Medical Device Establishment …

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

The MDEL fee for new and annual licence review applications. The MDEL fee is a flat fee regardless of when in the fiscal year the application is received. The …

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

See the Guidance document – Fees for the Review of Medical Device Establishment Licence Applications for more details. Government organizations – indicate if you are a …

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

Fees in Respect of Drugs and Medical Devices Order From Health Canada’s Regulatory Operations and Enforcement Branch In light of COVID-19, please only email any …

Payment Process | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-registration-and-listing/payment-process

The fee must be paid and you must receive confirmation that your payment has been processed before you can submit your annual establishment registration information …