The Health Sciences Authority (HSA) has introduced a series of regulatory initiatives aimed at strengthening oversight of medical devices while promoting innovation and timely patient access.
The updates cover software and AI-enabled medical devices, dealer licensing requirements, regulatory reliance, IVD reclassification, and Special Access Route (SAR) registration initiatives.
Read the full update here:
https://www.hsa.gov.sg/announcements/hsa-regulatory-updates-for-medical-devices-and-ivds—virtual-session-on-20-may-2026/
Purpose of the Update
To provide regulatory updates on medical devices and IVDs in Singapore.
To strengthen regulatory oversight while supporting innovation, registration efficiency, and timely access to safe medical devices.
Scope of Application
This update applies to medical device product owners, manufacturers, importers, dealers, and stakeholders involved in the registration, licensing, importation, supply, or post-market management of medical devices and IVDs in Singapore.
Key Highlights
Software and AI Oversight
New software and artificial intelligence (AI) guidelines will strengthen cybersecurity, machine learning controls, and oversight of AI-enabled medical devices.
A new Change Management Program (CMP) will allow eligible software updates to be implemented more efficiently.
Dealer Licensing Requirements
From 1 April 2026, medical device dealers must submit their latest audit reports together with quality management certificates when applying for or renewing licences.
Regulatory Reliance Pathway
HSA has introduced a regulatory reliance pathway with Malaysia’s Medical Device Authority (MDA), which may help eligible products reach the Singapore market faster.
IVD Reclassification
Effective 2 June 2026, COVID-19 diagnostic tests will be reclassified from Class D to Class C, lowering regulatory requirements.
HSA will also discontinue the IVD Cluster grouping.
Special Access Route (SAR)
Qualifying life-saving or legacy devices supplied through the Special Access Route (SAR) may receive registration fee waivers to encourage formal registration and improve patient access to essential medical devices.
Implications to Clients
The latest HSA updates aim to make medical device registration more efficient while maintaining patient safety.
Product owners and manufacturers will need to strengthen their software, cybersecurity, and AI documentation, but may benefit from faster approval pathways and fewer change submissions.
Importers and dealers must be prepared to provide audit reports and maintain stronger quality management systems.
Companies with products already registered in Malaysia may benefit from quicker access to the Singapore market through the regulatory reliance pathway.
COVID-19 test kits will face a lower regulatory burden following reclassification, while qualifying life-saving or legacy devices may receive registration fee waivers.
Overall, these changes encourage innovation, improve regulatory efficiency, and support faster patient access to safe medical devices.
Effective Date
As applicable to each initiative, including:
- Dealer licensing requirements: 1 April 2026
- COVID-19 diagnostic test reclassification: 2 June 2026
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Singapore, please contact sales@andamanmed.com.