The MHRA:
- has today published a statement of policy intent for international recognition of medical devices. It describes how the UK Government intends to recognise regulatory approvals from other countries (see CRCs below)depending on device type, class, and prior approval.
- 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.
- 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.
The proposed framework is still in draft, and the final version would be integral with the future core regulations.
With reference to the intended policy on international recognition, the comparable regulator countries (CRCs) for the proposed framework will be:
| Country | Agency |
|---|---|
| Australia | TGA |
| Canada | Health Canada |
| European Union | National competent authorities in the member states of the EU/ European Economic Area (EEA) |
| USA | FDA |
On this page, you can see the eligibility criteria for the framework and the exclusions from international recognition.
Source: MHRA