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January 31, 2026
Approximately 5 minutes
Singapore HSA Grouping Rules for IVD Analysers
Singapore HSA Grouping Rules for IVD Analysers
1. Purpose of Grouping
HSA allows grouping of IVD analysers to facilitate efficient registration for similar instruments from the same manufacturer. This approach reduces duplicate submissions for analysers with identical core technology and intended use while ensuring each proprietary name is distinctly listed on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
2. Eligibility Criteria
To qualify for grouping, analysers must meet all the following conditions:
- Same manufacturer / product owner
- Same risk classification (all Class B, C, or D)
- Same intended use category (e.g., clinical chemistry, haematology, immunoassay)
- Same core technical platform and operating principle (e.g., same detection method, fluidics system, software architecture)
- Similar or equivalent performance characteristics and risk profile https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
3. Allowed Variations within a Group
Permitted differences include:
- Variations in throughput capacity or sample handling volume
- Different user interface languages or software versions (with equivalent functionality)
- Minor changes in physical dimensions or aesthetics that do not affect analytical performance
- Different proprietary or brand names (each will be listed separately on SMDR)
Significant changes (e.g., new detection technology, different reagents compatibility, or altered intended use) disqualify grouping and require separate registration. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
4. Documentation Requirements
Grouped applications must include:
- Grouping rationale explaining similarities and justifying inclusion of all models
- Comparison table highlighting differences and demonstrating equivalence in safety and performance
- Representative technical documentation covering the group (e.g., common platform specifications)
- Individual labeling for each proprietary name variant https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
5. Registration and Listing Process
- The group is registered under one application
- Upon approval, each analyser with a unique proprietary name appears as a separate entry on the SMDR
- All models share the same registration number but are distinctly identified https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
6. Post-Registration Changes
- Adding new models with the same proprietary name that meet grouping criteria: submit a Change Notification
- Introducing analysers with new proprietary names: requires a new product registration application
- Major modifications to platform or performance: may trigger re-registration or separate application https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
7. Benefits and Practical Considerations
Grouping streamlines the registration of IVD analyser families, reducing time and cost for manufacturers offering multiple configurations of the same platform. Early consultation with HSA is recommended for borderline cases or complex families to confirm grouping eligibility. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
This policy supports efficient market access for IVD analysers in Singapore while upholding rigorous standards for analytical performance and patient safety. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-analysers
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