Fees Review Medical Device Licence Applications

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Medical Device User Fees | FDA

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

Complete the Medical Device User Fee Cover Sheet (Form FDA-3601) (see instructions in next section), if required. Send your payment with a completed copy of the Medical Device User Fee...

User Fees and Refunds for Premarket Approval …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-premarket-approval-applications-and-device-biologics-license-applications

The Medical Device User Fee Amendments of 2022 (MDUFA V), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees for 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

Guidance Document: Fees for the Review of Medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/fees-review-medical-device-licence-applications-2019/document.html

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 establishment …

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 …

Guidance Document - Fees for the Review of Medical …

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

A manufacturer is eligible for a remission of fees when the fee for the medical device licence application or licence amendment application is greater than 2.5% of the …

Fees for Medical Devices - Canada.ca

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

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

Frequently Asked Questions about Licensing - Medical …

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

To be eligible for a Multiple Products License, you must be distributing at least two of the following products: medical devices, food, nonprescription drugs, and compressed …

HSA | Fees and turnaround time for medical devices

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

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 informed that the …

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