How to Launch Your Medical Device or Health Product in Singapore: A Step-by-Step Guide
Navigate HSA regulations and enter Singapore's strategic healthcare market with expert local support and compliance guidance.
Singapore is one of the most tightly regulated and strategically positioned medical device markets in Asia. With the Health Sciences Authority (HSA) overseeing safety, performance, and compliance, international manufacturers must navigate registration, risk classification, quality systems, and local distribution requirements to enter the market successfully.
At Deyun, we act as your Singapore-based local liaison, handling regulatory submissions, local representation, and distribution. This allows you to focus on your core business while ensuring fast, compliant market entry.
Step 1: Determine Device or Health Product Classification
Identify Risk Class (GN-15 / GN-13):
Class A – Low risk (bandages, gloves)
Class B – Low–moderate risk (syringes, ultrasound systems)
Class C – Moderate–high risk (ventilators, implants, diagnostic software)
Class D – High risk (pacemakers, heart valves, implantable devices)
Map to Registration Pathway
GN-15 defines submission types: full, abridged, expedited, or immediate. Your classification affects documentation requirements and HSA review timelines.
Document Classification
Maintain a Device Master File (DMF) and Essential Principles Conformity Checklist (EPCC) for every product.
Step 2: Prepare Regulatory Documentation
International manufacturers must ensure:
Technical Documentation
Risk management (ISO 14971), design verification, clinical evidence for higher-risk devices
Supplier & CAPA Records
Demonstrate quality control and continuous improvement
Post-Market Surveillance
Describe complaint handling and field performance monitoring
Deyun reviews and organizes submissions to meet HSA expectations efficiently.
Step 3: Ensure Quality Management Compliance
Align your processes with GN-16 / ISO 13485:
- • Management responsibility and resource allocation
- • Design and development controls
- • Supplier and outsourced process oversight
- • Corrective and preventive actions (CAPA)
We provide local QMS support and audit readiness services, minimizing delays and compliance risks.
Step 4: Address Software, AI, and Digital Health Products
For Software as a Medical Device (SaMD) or AI-driven products:
Conduct risk-based classification per HSA GL-04 / GL-07 guidance
Validate algorithms and maintain lifecycle records
Prepare clinical performance documentation if applicable
Deyun ensures that software and digital products meet Singapore regulatory standards, reducing review cycles.
Step 5: Local Registration & Representation
HSA requires local representation for all international manufacturers.
As your authorized Singapore-based liaison, Deyun can:
Submit registration applications and technical documentation
Communicate with HSA on your behalf
Respond to regulatory queries promptly
This eliminates geographical and regulatory barriers for international companies.
Step 6: Implement UDI and Post-Market Surveillance
Assign Unique Device Identification (UDI) codes for traceability
Capture field performance data, complaints, and adverse events
Update risk management files and implement corrective actions as needed
Deyun monitors compliance on your behalf, ensuring ongoing market access.
Step 7: Distribution & Supply Chain Compliance
Adhere to SS 620 GDPMDS for storage, handling, and logistics
Ensure traceability and environmental control for sensitive products
Deyun provides turnkey distribution solutions, acting as your local partner to streamline supply chains
Conclusion
Entering Singapore's healthcare market requires regulatory expertise, local presence, and operational support. Partnering with Deyun ensures that international manufacturers:
Meet HSA registration and compliance requirements efficiently
Maintain high-quality standards and post-market monitoring
Access Singapore's market without the need for an in-country office
Ready to Enter Singapore's Healthcare Market?
Contact Deyun today for a customized Singapore market entry roadmap. Let us be your local liaison and simplify your regulatory and distribution journey.