Italy - UK - USA
MHRA publishes ‘Statement of policy intent: international recognition of medical devices’
- 21 May 2024
- Posted by: inetika
- Category: GLOBAL NEWS
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The UK Medicines and Health products Regulatory Agency (MHRA) has today published its ‘Statement of policy intent: international recognition of medical devices’.
This policy is intended to allow medical device manufacturers to use device clearances in other regulatory jurisdictions to ease entry to the GB (England, Scotland, Wales) market by recognising other international regulators’ approvals of medical devices.
Such recognition is intended to be available for devices with clearances in Australia, Canada, the European Union (EU), and the United States of America (USA), with certain exceptions.
Full details of the draft policy are available from this page of the MHRA website.
