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February 2, 2026
Approximately 5 minutes
Singapore HSA Single Device Registration Pathway
Singapore HSA Single Device Registration Pathway
1. Overview and Applicability
The single device registration pathway is the default route for medical devices that do not meet the eligibility criteria for any grouping category (such as family, system, IVD analysers, or others). It applies to standalone devices or products with unique characteristics requiring individual assessment. This pathway ensures thorough regulatory review tailored to each device's specific attributes, including design, materials, intended use, and risk profile. https://www.hsa.gov.sg/medical-devices/registration/grouping/single
2. When to Use Single Device Registration
A device must be registered individually if:
- It does not share sufficient common features with other models to qualify for grouping
- Variations exceed the limits allowed under family or system grouping rules
- It has a unique proprietary name, design, or intended use not covered by existing registrations
- It incorporates novel technology, materials, or performance claims requiring separate evaluation
Examples include first-in-class devices, significantly modified variants, or products from different manufacturers. https://www.hsa.gov.sg/medical-devices/registration/grouping/single
3. Key Requirements for Submission
Single device applications require full submission of the standard technical dossier, including:
- Device description and intended use
- Design and manufacturing information
- Risk management file
- Performance and safety testing data
- Labeling, instructions for use, and promotional materials
- Quality management system evidence (where applicable)
The documentation must be comprehensive and specific to the individual device, with no reliance on shared data from grouped products. https://www.hsa.gov.sg/medical-devices/registration/grouping/single
4. Risk Classification and Conformity Assessment
The registration requirements vary by risk class:
- Class A: Notification route (lowest regulatory control)
- Class B: Abbreviated or full evaluation
- Class C and D: Full evaluation, including higher scrutiny of clinical evidence and QMS
All single device registrations follow the risk-proportionate approach defined in HSA's classification rules. https://www.hsa.gov.sg/medical-devices/registration/grouping/single
5. Review and Approval Process
HSA conducts a thorough review focused on the device's specific attributes:
- Verification of conformity to Essential Principles of Safety and Performance
- Assessment of risk management and mitigation measures
- Evaluation of clinical/performance data (as required by class)
- Review of labeling and post-market surveillance plans
Timelines depend on risk class and completeness of submission. Approved devices receive a unique registration number and are listed individually on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/grouping/single
6. Post-Registration Obligations
After approval:
- Any change affecting safety, performance, or intended use requires a variation application
- Post-market surveillance, adverse event reporting, and field safety corrective actions apply as per HSA requirements
- Annual declaration of conformity may be required for certain classes
Single device registrations do not benefit from shared change notifications applicable to grouped products. https://www.hsa.gov.sg/medical-devices/registration/grouping/single
7. Practical Considerations
Single device registration is more resource-intensive than grouped pathways but is necessary for unique or highly differentiated products. Manufacturers should prepare detailed, device-specific documentation and consider pre-submission consultation with HSA for novel or complex devices to clarify expectations and reduce review cycles. https://www.hsa.gov.sg/medical-devices/registration/grouping/single
This pathway ensures rigorous evaluation of individual medical devices, supporting patient safety and regulatory compliance in Singapore's risk-based framework. https://www.hsa.gov.sg/medical-devices/registration/grouping/single
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