Medical Device Market Size
Market Value: Estimated at USD 1.1 billion in 2024. Singapore is a strategic hub for medical technology in Asia.
Growth Projections: Expected to grow at a modest pace, reaching USD 1.25 billion by 2029.
Future Growth Potential
- Regional Hub: Hosts regional HQs for several global medtech companies.
- Government Support: Investments in R&D and medical innovation under the Biomedical Sciences Initiative.
- Aging Population: One of Asia’s fastest-aging populations, leading to greater demand for home-use and monitoring devices.
Registration Process
Regulatory Authority: Health Sciences Authority (HSA) — Medical Devices Branch.
Device Classification:
- Class A — Low Risk
- Class B — Low to Moderate Risk
- Class C — Moderate to High Risk
- Class D — High Risk
Registration Requirements:
- Class A (Non-sterile): Exempt from registration, require dealer notification.
- Class B, C, D Devices: Require registration via HSA’s MEDICS online system. Abridged evaluation pathways available for devices with prior approvals (e.g., CE, FDA).
Local Representation: Foreign manufacturers must appoint a Registrant (typically a local distributor or agent) to submit applications.
Quality Management: ISO 13 485 required; devices must meet Essential Principles of Safety and Performance.
Fast Track Routes: GN-29 route allows abridged review based on approval in GHTF markets.
Online Portal: MEDICS portal — https://www.hsa.gov.sg/medics
Language Requirements: English is accepted for all submissions.
Post-Market Surveillance: Mandatory vigilance reporting and periodic safety updates.