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January 30, 2026
Approximately 5 minutes
Singapore HSA Grouping for Hearing Aids Registration
Singapore HSA Grouping for Hearing Aids Registration
1. Purpose of Grouping
HSA permits grouping of hearing aids to facilitate efficient registration when multiple models share the same fundamental design, technology, and intended performance. This reduces redundant submissions while ensuring all variants meet safety and effectiveness standards. Grouping is optional but encouraged when criteria are met. https://www.hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
2. Eligibility Criteria for Grouping
To qualify for grouping, hearing aids must satisfy all of the following:
- Same manufacturer
- Identical intended purpose and patient population
- Same classification (typically Class B)
- Same core technology and operating principle (e.g., same digital signal processing method)
- Same key components affecting performance and safety (e.g., microphone, receiver, processor)
- Same or equivalent materials in patient-contacting parts
- Same risk management outcomes https://www.hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
3. Allowed Variants within a Group
HSA permits limited variations within a single registration application:
- Differences in shell color, design, or aesthetics (non-functional)
- Minor changes in battery type or size (with equivalent performance)
- Variations in connectivity features (e.g., Bluetooth versions) if they do not alter core hearing amplification
- Different packaging or accessories that do not impact safety/efficacy
The maximum number of models/variants per group is typically 10. Larger groups require separate justification and may be split. https://www.hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
4. Documentation Requirements for Grouped Applications
In addition to standard registration documents, grouped submissions must include:
- A grouping rationale explaining similarities and justifying included variants
- A comparison table detailing differences and demonstrating equivalence
- Test reports or risk analyses confirming that variations do not adversely affect performance or safety
- Representative labeling for the group (with notes on variant-specific differences) https://www.hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
5. Evaluation and Post-Registration
HSA evaluates the group as a whole but may request individual testing data for high-risk variants. After approval:
- All models share the same registration number
- Changes to any variant require variation notification
- Post-market surveillance applies to the entire group https://www.hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
6. Benefits and Limitations
Grouping reduces administrative burden, fees, and review time for similar hearing aid models. However, non-qualifying differences (e.g., significant changes in amplification range or new signal processing algorithms) require separate registrations. Manufacturers should consult HSA early if uncertain about grouping eligibility. https://www.hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
This policy supports efficient market access for hearing aid variants in Singapore while maintaining rigorous safety and performance standards. https://www.hsa.gov.sg/medical-devices/registration/grouping/hearing-aids
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