ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The August 2025 cover features Parliament House in downtown Singapore.
Regulation
Authority: Health Sciences Authority (HSA)
Leader: Raymond Chua Swee Boon, CEO, HSA
Points of Interest:
- HSA boasts multiple streamlined, reduced-fee review pathways – the “immediate” route, the “abridged” route, and the “expedited” route. A device can access these routes based on its safety record and its authorization status with five trusted overseas authorities in the US, Australia, EU, Canada, and Japan.
- Stand-alone software authorized by a trusted country can benefit from “immediate” market access while HSA performs a backend review.
- Singapore has launched a novel cybersecurity “labeling scheme” tailored for devices, combining regulations and voluntary standards to incentivize security.
Market Access
Authority: Agency for Care Effectiveness (ACE)tk
Leader: Daphne Khoo, Executive Director, ACE
Points of Interest:
- ACE conducts technology assessments for new devices to inform government subsidies and hospital procurement.
- Most supplies are purchased centrally via the Agency for Logistics Procurement and Supply (ALPS) based on price, performance, reliability, and value-based metrics.
- Some higher-tech devices are procured at the hospital level, where clinician champions can sway decisions.
More Resources
- HSA hosts an easy-to-navigate website detailing the country’s device registration requirements. It includes interactive tools to help determine if a product is a medical device, its risk class, registration and licensing requirements, and whether you can group your devices into a single registration.
- Market Pathways’ wrote about Singapore’s novel Cybersecurity Labelling Scheme (MD) when it was first proposed in 2023. HSA launched the program in collaboration with three other agencies in 2024.
- ACE published its inaugural Innovation Trends Report July 16, spotlighting nine emerging medical technologies, including biodegradable implants, contactless patient monitoring, and digital therapeutics, that it anticipates will disrupt Singapore’s healthcare practice in the next five years.
