Medical Device Licensing Fees

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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

For an annual fee for periodic reporting concerning a class III device, 3.5 percent of the standard fee; For a 510 (k) premarket notification, 3.4 percent of the standard fee; For a 30-day notice, 1.6 percent of the standard fee; and For a 513 (g) request for classification information, 1.35 percent of the standard fee. See more

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 …

Medical Device User Fees | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/medical-device-user-fees

Oct 5, 2022

Who Must Register, List and Pay the Fee | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

The following charts detail the requirements for registration and listing based on the type of activity performed at that establishment. The chart also includes a column showing …

Medical Device Safety Program - California

https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/MedicalDeviceSafetyProgram.aspx

Medical Device License Fees (Effective July 1, 2022) (PDF) Medical Device Manufacturing Application: New Applicant, Ownership Change, Rewnewal, and …

Frequently Asked Questions about Licensing - Medical …

https://www.dshs.texas.gov/medical-device-manufacturers-distributors/licensing-requirements-medical-device-manufacturers-distributors

A manufacturer who also distributes other manufacturer’s devices at the same location, only needs to license as a device manufacturer. However, the licensing fee is based on the …

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 (selling) medical …

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 …

Fees for the Examination of an Application for a Medical …

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

Apr 1, 2022

HSA | Fees and turnaround time for medical devices

https://www.hsa.gov.sg/medical-devices/fees

Home Medical devices Fees and turnaround time for medical devices Here is the list of fees and turnaround times to help you with your medical device transactions. Please be …

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