At the end of April, it was announced that the MHRA of the United Kingdom was considering the approval of the FDA certified medical device products!

The UK Medicines Regulatory Authority (MHRA) and a number of government agencies have issued an update on their progress following the December 2022 joint statement. Relevant advisory groups have been established to reach consensus on international recognition, innovation routes and system capacity, demonstrating that the issues have been effectively addressed. Next, officials plan to evaluate the proposals from the advisory group by the end of April 2023 to ensure they meet relevant requirements and standards.

The ICAR agreed that in order to simplify the registration process for medical devices and reduce regulatory costs for small and medium-sized manufacturers, it is necessary to establish an equivalent path for medical devices certified by a credible regulatory body to avoid the burden of repeatedly submitting relevant information to multiple regulatory bodies.

Solutions to consider include:

Based on the current EU CE certification basis
Establish parity with trusted regulatory agencies, such as the US FDA, for most products