UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a consultation to seek views from interested stakeholders on proposals to update its statutory fees.
MHRA consultation on statutory fees - proposals on ongoing cost recovery are as follows.
1) Proposal 1
The MHRA proposes to increase the statutory fees shown in Annex B to ensure continued cost-recovery.
2) Proposal 2
The MHRA proposes to amend its existing Medical Device Registration fee to include the costs for medical device post-market work.
3) Proposal 3
The MHRA proposes to create a new service providing regulatory advice meetings for medical devices.
4) Proposal 4
The MHRA proposes to amend the fee model for three existing services(Scientific Advice Meetings, Control Testing, Unlicenced Medicines Importation), as well as increasing the fees to ensure continued cost recovery, and also to remove 51 fees that are no longer in use.
5) Proposal 5
The MHRA proposes to update and clarify the legal definition of a “standard variation” application for homeopathic products. The “standard variation” application statutory fee for homeopathic products will be unchanged.
The consultation will run from 29 August 2024 and close on 24 October 2024.
The implementation date for these proposed changes is April 2025.
Please see the attached file below for more details.
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