On 26 March 2025, the Medical Device Authority (MDA) announced the implementation of Circular Letter No. 1/2025, which supersedes Circular Letter No. 2/2014 regarding conformity assessment procedures for medical devices approved by recognised foreign regulatory authorities. This new circular was approved by the MDA Board and Top Management and took effect on 11 March 2025.
Key Highlights
In its official announcement, the MDA states that:
- Replacement of Previous Circular Letter
- Circular Letter No. 1/2025 officially supersedes Circular Letter No. 2/2014, introducing revised conformity assessment procedures for medical devices approved by recognized foreign regulatory authorities.
- Supporting Guidance Documents
- To facilitate compliance, two guidance documents have been developed:
- Mandatory Compliance for Medical Devices
- Medical devices approved by recognized foreign regulatory authorities must undergo conformity assessment procedures in accordance with the Circular Letter No. 1/2025 and the associated guidance documents.
Enquiries:
The MDA’s Feedback Management System (FEMES) is available for questions and further clarification.
For more detailed information, please refer to the MDA’s announcement accessible here:
If you would like to read the official guidance for medical device establishments, refer to the document here: Conformity Assessment by Way of Verification & Submission of Medical Device Registration in MeDC@St
For conformity assessment bodies (CABs), refer to this document: Conducting Conformity Assessment Through Verification.
Implications to Clients
Non-compliance may result in delays, penalties, or rejection of medical device registrations. Companies are advised to familiarise themselves with the revised procedures and ensure alignment with the new circular and guidance documents.
Effectivity Date
This announcement took effect on 11 March 2025.
