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February 1, 2026
Approximately 5 minutes
Singapore HSA IVD Cluster Grouping for Registration
Singapore HSA IVD Cluster Grouping for Registration
1. Purpose of IVD Cluster Grouping
HSA allows IVD reagents and test kits to be grouped into clusters to streamline registration for products that are closely related in function, technology, and clinical application. This enables a single registration application for multiple items within the same cluster, reducing administrative effort while ensuring each proprietary name variant is evaluated and listed separately on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
2. Eligibility Criteria
IVD products qualify for cluster grouping if they meet all of the following:
- Same product owner / manufacturer
- Same risk classification (all Class B, C, or D)
- Same intended purpose and clinical indication
- Same core detection technology / methodology (e.g., same immunoassay format, same nucleic acid amplification principle)
- Same or equivalent analyte / target specificity
- Comparable specimen types and performance profile https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
3. Cluster Composition
A cluster typically includes:
- Multiple test kits or reagent sets targeting the same analyte or panel using the same technology
- Different proprietary names or brand variants of the same underlying test system
- Accessories or supplementary reagents designed specifically for use with the cluster's primary tests
Clusters are analyte- or technology-centric, allowing grouping of related diagnostic products rather than unrelated items. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
4. Allowed Variations within a Cluster
Permitted differences include:
- Variations in kit configuration (e.g., number of tests, inclusion of controls)
- Minor formulation adjustments in non-critical reagents that do not affect performance
- Different packaging sizes or formats
- Different proprietary names, model numbers, or branding
Significant changes (e.g., different analytes, new technology platform, altered clinical claims) disqualify inclusion in the cluster and require separate registration. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
5. Documentation Requirements
Cluster grouping applications must include:
- A cluster rationale explaining the common technology, analyte, and purpose
- A comparison matrix for all products in the cluster, highlighting differences and demonstrating equivalence
- Representative technical documentation covering the cluster (e.g., shared validation studies, risk assessment)
- Individual labeling, instructions for use, and package inserts for each proprietary name https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
6. Registration and Listing Process
- The entire cluster is submitted and registered under one application
- Upon approval, each product with a unique proprietary name is listed separately on the SMDR
- All items in the cluster share the same registration number but are distinctly identified https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
7. Post-Registration Obligations
- Adding new products that fit the existing cluster and share the same proprietary name family: submit a Change Notification
- Introducing new proprietary names or major modifications: requires a new registration application
- Changes affecting cluster performance or intended use: may trigger re-evaluation or separate registration https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
8. Benefits and Practical Considerations
Cluster grouping optimizes registration for families of related IVD products, lowering time and cost for manufacturers while ensuring thorough assessment. Manufacturers should consult HSA early for large clusters or complex variations to confirm eligibility and documentation needs. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
This framework supports efficient market entry for diagnostic IVD clusters in Singapore while maintaining high standards of analytical and clinical performance. https://www.hsa.gov.sg/medical-devices/registration/grouping/ivd-cluster
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