The Health Sciences Authority (HSA), Singapore, seeks public consultation on exemptions from manufacturer licensing and product registration requirements for Artificial Intelligence (AI) – Software as Medical Devices (SaMDs) developed by MOH Holdings Pte Ltd (MOHT), Synapxe Pte Ltd (Synapxe), and public healthcare clusters/institutions.
Scope of AI-SaMD for Proposed Exemptions
- Class A and B
- Developed under the supervision and oversight of a clinician (with the position of Consultant or higher) employed by a public healthcare institution
- Developed for in-house use only (by licensed healthcare institutions)
Expected Benefits
- Elimination of duplicated costs
- Facilitation of the use of identical AI-SaMD functions across multiple public healthcare institutions
- Others
Feedback Period
19 May 2025 to 19 Jun 2025
Feedback Form
https://form.gov.sg/681db02e08ec7d1313dd8b18
View full advisory here:
https://www.hsa.gov.sg/announcements/public-consultation/proposedexemption-AI-SaMD
Implications to Clients
An opportunity to shape regulatory controls for AI-SaMD development and use within Singapore’s public healthcare system.
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