MHRA Announces A Proposed Framework For International Recognition of Medical Devices.
This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health,
The Medicines and Healthcare products Regulatory Agency (MHRA) has (on 21 May 2024) published a statement of policy intent for international recognition of medical devices.
The MHRA’s statement of policy intent describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the European Union and the United States of America depending on device type, class, and prior approval. The MHRA continues to review the list of comparable regulator countries and is in active discussions with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan.
The MHRA’s statement of policy intent focuses on ensuring safe access to quality-assured medical devices and reducing the duplication of assessments by comparable regulators to enable resource to be focused on more innovative products for the benefit of patient health. This statement will also allow manufacturers to start considering whether their devices will be eligible for the proposed alternative routes to market.
The proposed framework is still in draft, and the final version would be integral with the future core regulations.
More information on Statement of policy intent: international recognition of medical devices is available on the following link
Statement of policy intent: international recognition of medical devices - GOV.UK (www.gov.uk) To get more of such regulatory update insight follow Sushvin Consultancy Services LinkedIn Page.
