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January 30, 2026
Approximately 5 minutes
Singapore HSA System Grouping for Medical Device Registration
Singapore HSA System Grouping for Medical Device Registration
1. Purpose of System Grouping
HSA permits grouping of medical devices as a 'system' to streamline registration for products comprising multiple interdependent components that function together as an integrated unit. This allows a single product registration application for the entire system, reducing duplication while ensuring all components meet safety and performance standards. Each system is registered under one application, with individual components or configurations listed separately if they have distinct proprietary names on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/grouping/system
2. Eligibility Criteria for System Grouping
Devices qualify as a 'system' for grouping if they satisfy all the following:
- Same product owner / manufacturer
- Same risk classification (all components in the same class, typically B, C, or D)
- Components are intended to function together as a single integrated system
- Same overall intended purpose (the system as a whole achieves the intended medical objective)
- Interdependent design where components are not independently functional for the intended use
- Consistent risk management outcomes across the system https://www.hsa.gov.sg/medical-devices/registration/grouping/system
3. Typical Examples of Systems
Common examples eligible for system grouping include:
- Modular orthopaedic implant systems (e.g., hip replacement with various stem, head, and cup combinations)
- Interventional cardiology systems (e.g., stent delivery system with catheter, balloon, and stent)
- Dialysis systems (e.g., machine with compatible tubing sets and filters)
- Infusion pump systems with dedicated administration sets
- Endoscopic systems with scope, light source, and accessories designed to work together https://www.hsa.gov.sg/medical-devices/registration/grouping/system
4. Allowed Variations within a System
Permitted variations include:
- Configurable combinations of compatible components (e.g., different sizes or lengths within specified ranges)
- Different proprietary names for system configurations or subsets
- Minor accessory variations that do not alter core system performance
Independent devices that can function separately or significant changes (e.g., new component altering intended use) do not qualify for system grouping and require separate registration. https://www.hsa.gov.sg/medical-devices/registration/grouping/system
5. Documentation Requirements
System grouping applications must include:
- A grouping rationale describing the integrated function and justifying inclusion of all components/configurations
- A system description outlining interdependencies and compatibility
- A comparison matrix for configurable options, demonstrating equivalence in safety and performance
- Representative technical files covering the system as a whole (e.g., risk analysis, performance testing)
- Individual labeling for each proprietary name or major configuration https://www.hsa.gov.sg/medical-devices/registration/grouping/system
6. Registration and Listing Process
- The system is submitted and registered as one application
- Upon approval, configurations or components with unique proprietary names are listed separately on the SMDR
- All elements share the same registration number but are distinctly identified https://www.hsa.gov.sg/medical-devices/registration/grouping/system
7. Post-Registration Obligations
- Adding new compatible configurations with the same proprietary name: submit a Change Notification
- Introducing new proprietary names or major components: requires a new product registration application
- Significant system modifications: may necessitate re-registration or separate application https://www.hsa.gov.sg/medical-devices/registration/grouping/system
8. Benefits and Practical Considerations
System grouping optimizes registration for complex, modular devices, reducing time and cost for manufacturers while maintaining rigorous oversight. Manufacturers should consult HSA early for borderline cases or large systems to confirm eligibility and ensure appropriate documentation. https://www.hsa.gov.sg/medical-devices/registration/grouping/system
This policy supports efficient market access for integrated medical device systems in Singapore while upholding high standards of safety and performance. https://www.hsa.gov.sg/medical-devices/registration/grouping/system
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