Medical Device Regulatory Reliance with Medical Device Authority (MDA) of Malaysia
The Medical Device Authority (MDA) of Malaysia and the Health Sciences Authority (HSA) of Singapore signed a Memorandum of Understanding (MoU) during the 14th ASEAN Medical Device Committee (AMDC) Meeting held in Siem Reap, Cambodia on 22 August 2025. The authorities also jointly launched a 6-month pilot of the Medical Device Regulatory Reliance Programme which will run from 1 September 2025 to 28 February 2026, as part of the MoU.
This regulatory cooperation under the Malaysia-Singapore Medical Device Regulatory Reliance Programme is designed to facilitate a streamlined registration process of medical devices between both countries, and for Class B, C and D medical devices.
The pilot phase of the 6-month Medical Device Regulatory Reliance Programme will focus on optimising regulatory processes and coordination mechanisms while assessing the effectiveness of the programme.
Medical Device Registration Certificate Holders participating in the pilot can expect reduced review times for medical device registration in both countries:
- In Malaysia: Devices registered with HSA may undergo a verification route (abridged review pathway) through MDA's Conformity Assessment Body (CAB). The review is expected to take 30 working days, compared to 60 working days under the full conformity assessment route. The device will then be registered within 30 working days.
- In Singapore: Devices registered with MDA will benefit from an abridged review pathway, achieving up to 30% shorter review times across all Class B to D medical devices.
Application Process
Documentary Requirements:
- The letter requesting participation in the Malaysia-Singapore Medical Device Regulatory Reliance Programme, containing registration information from the Medical Device Authority Register (MDAR), must be signed by the local applicant (Registrant).
- The applicant must submit this letter along with all required registration documents as specified in GN-15: Guidance on Medical Device Product Registration, based on the Abridged evaluation route on the online Singapore Health Product Access and Regulatory E-System (SHARE).
Online Submission:
While HSA enhances SHARE to include the Regulatory Reliance Program Option, applicants should:
- Initial Application Steps:
- Select "None of the above" under Evaluation Route Determinants
(Note that the application will display "Full" as the evaluation route) - Upload the required documents in SHARE
- Post-Submission Process:
- To ensure application receives the correct abridged evaluation processing, please email hsa_md_info@hsa.gov.sg with application number. HSA will:
- Adjust the fees accordingly through offline processing
- Apply the shorter abridged evaluation turnaround time (TAT) offline
This temporary arrangement will be in place until the SHARE system enhancement is complete.