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February 1, 2026
Approximately 5 minutes
Singapore HSA Grouping Guidelines for FISH Probes IVD
Singapore HSA Grouping Guidelines for FISH Probes IVD
1. Purpose of Grouping
HSA allows grouping of Fluorescence In Situ Hybridization (FISH) probes IVD reagents and accessories to streamline registration when they meet specific criteria. This enables multiple products based on FISH methodology to be registered together in one application, reducing administrative burden while maintaining regulatory oversight. https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
2. Eligibility Criteria
Products can be grouped if they meet all the following:
- From the same product owner
- Same risk classification (all Class B or all Class C)
- Based on fluorescence in situ hybridization (FISH) methodology
- Fall within the same predefined FISH probes IVD grouping category (a closed list) https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
3. Grouping Categories
The predefined categories include:
- Selective therapy (e.g., ALK gene, HER2)
- Pre-natal testing (e.g., Chromosomes 13, 21, 18, X and Y)
- Genetic testing of inheritable disease (e.g., ELN gene)
- Pathogen identification (e.g., Mycobacterium tuberculosis complex, Escherichia coli)
- Hematologic disorder and blood cancer markers (e.g., Chromosomes 3, 7, 9 and 11)
- Other cancer markers (e.g., LAMP2 gene, Topoisomerase 2A gene)
Reagents and accessories for multiple uses can be grouped under any one qualifying category. https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
4. Allowed Variations
- Different proprietary or brand names within the same category are permitted; each will be listed separately on the Singapore Medical Device Register (SMDR)
- For products spanning multiple categories, select one qualifying category for grouping https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
5. Documentation Requirements
Submit information supporting the intended purposes of all grouped reagents and accessories as part of the product registration application. https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
6. Evaluation Process
- The grouped products are registered together in one application
- Approved products with different proprietary names appear as separate listings on the SMDR https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
7. Post-Registration Obligations
- To add new models with the same proprietary name that fulfill the grouping criteria, submit a Change Notification
- For new devices with different proprietary names, a new product registration application is required https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
8. Benefits and Limitations
Grouping enables efficient registration of multiple FISH probes in one application if criteria are met, with separate SMDR listings for different names. Limitations include restriction to same owner, class, methodology, and category—no cross-category grouping. https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
9. Examples
Manufacturer HSA Zen produces HSA Zen ABC FISH Probes Kit (Selective Therapy) and HSA Zen XYZ FISH Probes Kit (Selective Therapy); both can be grouped under Selective Therapy, registered together, and listed separately on SMDR due to different names. https://www.hsa.gov.sg/medical-devices/registration/grouping/fish-probes-ivd
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