Singapore-Malaysia Medical Device Regulatory Reliance Programme

1. Overview

The Health Sciences Authority (HSA) of Singapore and the Medical Device Authority (MDA) of Malaysia signed a Memorandum of Understanding (MoU) on 22 August 2025 during the 14th ASEAN Medical Device Committee Meeting. As part of this MoU, they jointly launched a 6-month pilot of the Medical Device Regulatory Reliance Programme running from 1 September 2025 to 28 February 2026. Source: https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/regulatory-reliance

2. Purpose and Scope

The programme enables streamlined registration of Class B, C and D medical devices between Singapore and Malaysia by allowing each authority to rely on the other's assessment. This reduces duplication, speeds up market access, and maintains safety standards. Source: https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/regulatory-reliance

3. Benefits for Applicants

• In Malaysia: Devices registered with HSA undergo a verification route (abridged review) via MDA’s Conformity Assessment Body (CAB), with review expected in 30 working days (vs 60 days full route), followed by registration in 30 working days.
• In Singapore: Devices registered with MDA benefit from an abridged review pathway, achieving up to 30% shorter review times across Class B to D devices.

Source: https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/regulatory-reliance

4. Application Process

1. Submit a signed letter requesting participation in the Singapore-Malaysia Medical Device Regulatory Reliance Programme (template available on the page), including registration details from the Medical Device Authority Register (MDAR).
2. Submit the letter plus all required registration documents via the Singapore Health Product Access and Regulatory E-System (SHARE) under the Abridged evaluation route.
3. While SHARE is being enhanced, select “None of the above” under Evaluation Route Determinants, upload documents, then email hsa_md_info@hsa.gov.sg with the application number so HSA can adjust fees and apply the shorter turnaround time offline.

Source: https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/regulatory-reliance

5. Important Notes

• The pilot is temporary (6 months) to optimise processes and assess effectiveness.
• Full conformity assessment remains available if needed.
• Last updated: 31 Dec 2018 (page template; programme launched 2025). Source: https://www.hsa.gov.sg/medical-devices/international-collaboration-medical-devices/regulatory-reliance