How to Launch Your Medical Device in Singapore: A Step-by-Step Market Entry Guide
Navigate HSA regulations and enter Singapore's strategic healthcare market with compliance confidence.
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.
To ensure fast, compliant market entry, manufacturers must understand the specific regulatory framework and the requirement for local representation.
Step 1: Determine Device Classification
First, identify the risk class of the device based on HSA Guidance GN-13 (for General Medical Devices) or GN-14 (for In Vitro Diagnostics):
Class A – Low risk (e.g., bandages, surgical masks)
Class B – Low–moderate risk (e.g., hypodermic needles, ultrasound systems)
Class C – Moderate–high risk (e.g., lung ventilators, orthopedic implants)
Class D – High risk (e.g., pacemakers, heart valves, stents)
Note: Therapeutic products (pharmaceuticals) follow a separate forensic classification system (POM, P, GSL) and distinct registration pathways.
Step 2: Prepare Regulatory Documentation
Once classified, the technical dossier must be prepared. Singapore follows the ASEAN Common Submission Dossier Template (CSDT). Key requirements include:
Essential Principles Conformity Checklist (EPCC)
Mandatory for all classes
Risk Management
Evidence of compliance with ISO 14971
Clinical Evidence
Required for higher-risk devices (Class C/D) and novel technologies
Design Verification
Proof of safety and performance testing
Step 3: Ensure Quality Management Compliance
Manufacturing and distribution processes must align with HSA GN-16 and ISO 13485 standards. Manufacturers must demonstrate:
- • Management responsibility and resource allocation
- • Design and development controls
- • Strict supplier and outsourced process oversight
- • A robust Corrective and Preventive Actions (CAPA) system
Step 4: Address Specific Requirements (Software/AI)
If the product is Software as a Medical Device (SaMD) or AI-driven, additional criteria apply:
Classification
Conduct risk-based classification per HSA Guidelines GL-04
Cybersecurity
Ensure compliance with HSA Guidelines GL-08
Lifecycle
Validate algorithms and maintain lifecycle management records (GL-07)
Step 5: Submit via SHARE Portal
HSA requires registration and electronic submissions to be made under a Singapore-registered Registrant account (via the HSA SHARE portal).
Important:
Foreign manufacturers without a Singapore legal entity cannot submit directly. They must appoint a Singapore-based Registrant to act as the legal representative and point of contact.
The appointed Registrant is responsible for:
Preparing and submitting registration applications via SHARE
Responding to HSA queries and technical input requests
Fulfilling local post-market obligations on behalf of the manufacturer
Step 6: Finalize Market Readiness
Before the first sale, ensure operational compliance:
UDI Compliance
Assign Unique Device Identification (UDI) codes for traceability (phased implementation)
Post-Market Surveillance
Set up a system to capture field performance data, complaints, and adverse events (FSCA/AE reporting)
Risk Updates
Continuously update risk management files based on real-world data
Step 7: Distribution & Supply Chain Compliance
To physically distribute products in Singapore, importers and wholesalers must adhere to SS 620:2016 (GDPMDS) — Good Distribution Practice for Medical Devices. This ensures:
Proper storage and handling conditions (temperature/humidity monitoring)
Traceability throughout the supply chain
Segregation of non-conforming products
Conclusion
Entering Singapore's healthcare market requires regulatory expertise, local presence, and operational precision. By rigorously adhering to HSA standards and appointing a qualified local Registrant, international manufacturers can:
Meet registration and compliance requirements efficiently
Maintain high-quality standards and post-market monitoring
Access Singapore's market without the immediate 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.