Approval Issued by Health Science Authority (HSA) Permitted by MDA for Conformity Assessments by Way of Verification Process

The Medical Device Authority (MDA) and the Health Sciences Authority (HSA) of Singapore remain committed to enhancing regulatory efficiency and facilitating timely access to medical devices within the region. Through the establishment of a regulatory reliance framework, both agencies aim to streamline registration processes while maintaining high standards of safety, quality, and performance.

The six (6)-month pilot implementation of the Medical Device Regulatory Reliance Programme between MDA and HSA conducted from 1 September 2025 to 28 February 2026, has been successfully completed. Following the successful implementation of the pilot phase, application for Class B, C and D medical devices that have been registered in the Singapore Medical Device Register (SMDR), registration applications for the medical devices will continue to be accepted by MDA through the Verification Route (Reference: MDA/GD/0070 – Establishment Guide to Medical Device Registration Submission in MeDC@St through Conformity Assessment by Way of Verification Process). Given the success of this pilot project, the official joint statement regarding full implementation details of this programme will be released during the 29th IMDRF in Singapore.

MDA wishes to express its appreciation to industry stakeholders for their cooperation and participation throughout the pilot phase. Continued engagement from industry remains essential in strengthening regulatory collaboration and improving access to medical devices within the region.

This arrangement shall take effect from 1 March 2026.

For any technical inquiries regarding submissions, please contact the Registration Team at registration@mda.gov.my.

Medical Device Authority (MDA)

Ministry of Health Malaysia

1 March 2026