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February 2, 2026
Approximately 5 minutes
Singapore HSA Grouping Guidelines for IVD Test Kits
Singapore HSA Grouping Guidelines for IVD Test Kits
1. Purpose of Grouping IVD Test Kits
HSA allows grouping of IVD test kits to facilitate efficient registration when multiple kits share essential characteristics. This enables a single product registration application for related test kits, reducing redundancy while maintaining rigorous evaluation of each proprietary name variant. Approved kits with different proprietary names are listed separately on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
2. Eligibility Criteria
IVD test kits qualify for grouping if they meet all the following conditions:
- Same product owner / manufacturer
- Same risk classification (all Class B, C, or D)
- Same analyte / biomarker / target (e.g., same specific antigen, antibody, or nucleic acid sequence)
- Same detection principle / methodology (e.g., ELISA, lateral flow, PCR, chemiluminescence)
- Same intended use and clinical indication
- Comparable specimen types and performance characteristics https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
3. Allowed Variations within a Group
Permitted differences include:
- Different proprietary names, brand names, or trade names
- Minor variations in kit components (e.g., buffer composition, conjugate concentration) that do not alter analytical or clinical performance
- Different packaging formats or kit configurations (e.g., number of tests per kit)
- Variations in labeling or instructions that do not affect use or interpretation
Significant differences — such as different analytes, detection methods, specimen types, or performance claims — disqualify grouping and require separate registration. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
4. Documentation Requirements
Grouped IVD test kit applications must include:
- A grouping rationale explaining similarities and justifying inclusion of all kits
- A comparison table detailing differences (e.g., proprietary names, minor formulation changes) and demonstrating equivalence in performance, sensitivity, specificity, and safety
- Representative technical documentation covering the common test principle (e.g., shared validation data, risk analysis)
- Individual labeling, instructions for use, and package inserts for each proprietary name variant https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
5. Registration and Listing Process
- The grouped test kits are submitted and registered under one application
- Upon approval, each kit with a unique proprietary name is listed as a separate entry on the SMDR
- All kits in the group share the same registration number but are distinctly identified https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
6. Post-Registration Changes
- Adding new kits with the same proprietary name that meet grouping criteria: submit a Change Notification
- Introducing kits with new proprietary names: requires a new product registration application
- Major changes to analyte, method, performance, or intended use: necessitate re-registration or separate application https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
7. Benefits and Practical Considerations
Grouping streamlines registration for families of IVD test kits targeting the same analyte with the same method, reducing time and cost for manufacturers. Early consultation with HSA is recommended for complex kits or borderline variations to confirm grouping eligibility and ensure appropriate documentation. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
This policy supports efficient market access for related IVD test kits in Singapore while upholding strict standards for diagnostic accuracy, reliability, and patient safety. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-test-kit
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