The MHRA has announced a policy intent to recognize medical device regulatory approvals from Australia, Canada, the EU, and the USA, aiming to ensure safe access to quality devices and reduce assessment duplication.
There is an ongoing discussions to include Japan on the recognition approval. The proposed framework is still in draft, and the final version would be integral with the future core regulations which are aiming to be in force in 2025. Here is the press release.
International recognition will enable the MHRA to leverage the expertise and decisions of other regulatory partners for patient benefit and to be focused on more innovative products , while maintaining the authority to reject applications if the provided evidence is deemed inadequate. Here is the full Statement of policy intent.