Registration Support Initiative for Unregistered Medical Devices

The Health Sciences Authority (HSA) is introducing a Registration Support Initiative to facilitate the transition of clinically important unregistered medical devices from the Special Access Route (SAR) onto a sustainable formal registration pathway. While SAR serves a critical role in enabling patient access to unregistered devices in exceptional circumstances, it is not intended as a long-term supply mechanism. Recognising that certain devices — particularly those serving small patient populations with limited commercial viability in the Singapore market — may face barriers to registration, HSA will waive evaluation fees for eligible devices to reduce the regulatory cost of registration. Clinicians are invited to identify devices in their practice that may qualify, complete a Clinical Justification and Endorsement Form, and connect with their device supplier to initiate the process. The inaugural application window is open until 31 December 2026. Thereafter, the initiative will be open annually from 1 October to 31 December. This initiative seeks to provide a more sustainable supply pathway for devices that continue to meet important clinical needs in Singapore. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system. 

Step 1: Select your profession under ‘For Healthcare Professionals’. 

Step 2: Click on ‘Useful links’. 

Step 3: Click on ‘MOH Alert’ and log in via Singpass. 

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.