Summary
Creates a regulatory sandbox exemption for qualifying artificial-intelligence software as a medical device developed by selected public healthcare entities for use in public healthcare. The exemption relieves covered AI-SaMD from manufacturer licensing and product registration requirements, subject to safeguards including Class A or B scope, non-critical medical-condition use, clinician oversight, yearly ISO 13485 QMS self-attestation, senior institutional endorsement, HSA pre-deployment notification, patient notification, post-market obligations, and enforcement for breaches.
Healthcare Implications
Enables selected Singapore public healthcare institutions to deploy lower-risk AI-SaMD under controlled conditions while maintaining clinical oversight, quality-system expectations, patient notice, HSA visibility, adverse-event reporting, and enforcement. Developers and health systems outside the selected public-healthcare pathway should treat this as a limited regulatory sandbox, not a general AI-SaMD market-access exemption.