Medical Device Registration in Singapore: The HSA Approval Process is the method needed by the Health Sciences Authority (HSA) to lawfully sell or distribute medical devices in Singapore. This method guarantees that only safe, effective, and high-quality medical equipment are offered on the market. The registration process includes defining the device classification, producing technical papers, submitting applications via HSA’s online system (SHARE), and satisfying post-market duties once approved.
Who Regulates Medical Devices in Singapore?
The Health Sciences Authority (HSA) regulates all medical devices in Singapore under the Health Products Act and its related regulations.
HSA is responsible for:
- Evaluating and approving devices before they enter the market
- Monitoring post-market safety
- Issuing licenses for importers, manufacturers, and distributors
- Enforcing compliance and recalls if needed
Why is Medical Device Registration Required in Singapore?
Medical Device Registration in Singapore ensures:
- Patient safety and product quality
- Regulatory traceability of devices sold in the market
- Compliance with Singapore’s legal standards
- Global credibility for manufacturers exporting from Singapore
Without HSA approval, it is illegal to import, manufacture, or sell a medical device in Singapore.
How Are Medical Devices Classified by HSA?
HSA classifies medical devices into four risk-based categories — Class A, B, C, and D.
| Class | Risk Level | Examples | Registration Requirement |
| Class A | Low | Surgical Gloves, Wheelchairs | Notification only |
| Class B | Low to Moderate | Suction pumps, dental materials | Registration required |
| Class C | Moderate to High | Dialysis machines, infusion pumps | Registration required |
| Class D | High | Heart Valves, pacemakers | Registration required |
What Are the Evaluation Routes Under HSA?
The evaluation route depends on the device’s risk class and existing international approvals.
| Route | When Applicable | Description |
| Full Route | No prior approvals | Complete review of technical data and safety documents |
| Abridged Route | Approved by 1+ recognised regulators | Reduced data requirement and shorter timeline |
| Expedited Route | Approved by 2+ reference agencies | Faster approval based on recognised certifications |
| Immediate Route | Well-established devices with multiple approvals | Instant listing after document verification |
Who Can Apply for Medical Device Registration in Singapore?
Only a Singapore-based entity, known as a Registrant, can submit the application to HSA.
The Registrant can be:
- The manufacturer’s local office
- An authorized distributor or agent
- A third-party regulatory representative
What Documents Are Required for HSA Medical Device Registration?
To register your device with HSA, the following documents are generally required:
Basic Documents
- Application form and cover letter
- Device description and intended use
- Classification rationale
- List of configurations and variants
Technical Documentation
- Design and manufacturing details
- Risk analysis and ISO 14971 compliance
- Quality Management System (QMS) certificate (ISO 13485)
- Safety and performance test reports
- Clinical evaluation report (for Class C/D devices)
- Labeling, packaging, and Instructions for Use (IFU)
- Copies of foreign approvals or certificates (if applicable)
What Is the HSA Submission Process for Medical Device Registration?
The HSA submission follows a structured step-by-step process through the SHARE portal:
Step 1: Classification
Determine your device’s risk class using HSA’s classification guidelines.
Step 2: Appoint a Registrant
Only a Singapore-based Registrant can submit the application.
Step 3: Prepare Technical Documents
Organize data according to HSA’s GN-15 Guidance format.
Step 4: Submit Application on SHARE
Upload all documents and pay the screening fee.
Step 5: HSA Screening & Evaluation
HSA checks completeness, asks for clarifications (if needed), and performs technical review.
Step 6: Approval & Listing
If approved, the device is added to the Singapore Medical Device Register (SMDR).
Step 7: Maintain Compliance
Submit post-approval notifications, renewals, and vigilance reports as required.
What Are the HSA Registration Fees and Timelines?
Registration fees vary by device class and evaluation route.
| Device Class/Route | Approximately Evaluation Fee (SGD) | Estimated Processing Time |
| Class A (Notification) | 25 – 100 | Immediate |
| Class B (Full) | 4,000 – 5,000 | 6–9 months |
| Class C (Abridged) | 8,000 – 10,000 | 4–6 months |
| Class D (Expedited/Full) | 12,000+ | 8–12 months |
What Happens After Device Approval?
After the device is approved and listed on SMDR, the Registrant must:
- Maintain the registration validity
- Submit change notifications for any design or labeling modifications
- Renew licences periodically
- Report adverse events and recalls promptly
- Ensure all dealers are licensed and comply with Good Distribution Practice (GDP)
Failure to follow post-market obligations may lead to suspension or cancellation of registration.
What Are the Common Reasons for Delayed HSA Approvals?
Common causes of delays include:
- Incorrect device classification
- Missing or incomplete technical documentation
- Lack of a valid local Registrant
- Delayed responses to Input Requests (IRs) from HSA
- Non-compliance with HSA dossier structure or labeling rules
What Is the Typical Timeline for Medical Device Registration in Singapore?
While timelines vary, below is a general estimation:
| Process Stage | Duration (Approx) |
| Device classification & dossier preparation | 2–4 weeks |
| HSA screening | 2–6 weeks |
| Technical evaluation | 4–12 months (depends on route) |
| Approval & listing on SMDR | 1–2 weeks post-approval |
What Are the Key HSA Guidelines to Follow?
Important official guidelines include:
- GN-15: Guidance on Medical Device Product Registration
- GN-21: Change Notification Guidance
- GL-07: Software as a Medical Device (SaMD) Guidance
- GN-12: Grouping of Medical Devices
- HSA SHARE Portal User Manual
How ELT Corporate Can Help You with Medical Device Registration in Singapore?
ELT Corporate is one of the best regulatory consultancy firms in India and abroad, offering complete assistance in Medical Device Registration in Singapore.
- Expert team familiar with HSA’s regulatory framework
- Assistance in device classification and dossier preparation
- Help in appointing a local Registrant
- Support in SHARE submission and document compilation
- Guidance through evaluation, queries, and approvals
- Assistance in post-market compliance and change notifications
- Affordable packages for multi-country device registrations
- Experience with HSA, CDSCO, and other global authorities
Conclusion
The Health and Safety Authority (HSA) Approval Process is an essential component in the process of ensuring that only safe and effective medical devices are made available to patients in Singapore. A number of important processes include gaining an understanding of the risk categorisation of your product, choosing the appropriate assessment path, putting together a comprehensive dossier, and ensuring post-market compliance. Streamlining the whole process, avoiding regulatory traps, and gaining speedier market access in Singapore are all things that manufacturers may do with the assistance of ELT Corporate’s technical assistance.
What is the role of HSA in Singapore?
HSA is the government authority responsible for regulating and approving medical devices to ensure safety and quality.
Can a foreign manufacturer register directly with HSA?
HSA is the government authority responsible for regulating and approving medical devices to ensure safety and quality.
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