The Living Dossier
From one-time approvals to continuous lifecycle management: algorithm change management and real-world performance monitoring.
Free field guide · PDF
Singapore HSA: AI Medical Devices2026 Field Guide
The Living Dossier, the AIHGle 2.0 rules, and the reliance lane — with the HSA AI practice you need.
- Dossier model
- Living
- AIHGle
- 2.0
- Review days
- 160–310
Sourced from verified 2026 publications.
Download the free guide
Enter your work email and we'll send the PDF straight to your inbox.
What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The AIHGle 2.0 rules
Clinical transparency, model validation, ongoing risk management — plus IEC 62304 and MLMD evaluation standards.
The reliance lane
The SG-MY reliance pilot for Class B–D devices and the full-evaluation working-day timelines.
Sources & scope
- youtube.com (Pure Global), Singapore's AI MedTech Rules & The 'Living Dossier' Headache.
- operonstrategist.com, Wearable Medical Device Registration in Singapore: HSA Guide.
- sbr.com.sg, HSA clears cancer-detecting AI for routine hospital use.
This guide is market-access intelligence, not regulatory or legal advice. HSA AI requirements, lifecycle rules, and reliance pilots change — professional review is required before business use.
Market Access Strategy Session
Singapore AI on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your HSA AI route — Living Dossier setup, AIHGle 2.0 compliance, and reliance strategy.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team