Singapore HSA Device Grouping for Registration

1. Purpose of Grouping

HSA permits grouping of medical devices to streamline the registration process for products that are closely related in design, technology, and intended use. This allows multiple similar devices to be submitted in a single application, reducing administrative burden while maintaining regulatory oversight for safety and performance. Grouped devices share one registration but are listed individually on the Singapore Medical Device Register (SMDR) if they have different proprietary names. https://www.hsa.gov.sg/medical-devices/registration/grouping/group

2. Eligibility Criteria

Devices qualify for grouping if they meet all of the following conditions:

• Same product owner / manufacturer
• Same risk classification (all devices in the group belong to the same class: A, B, C or D)
• Same intended purpose and target patient population
• Same fundamental design and operating principle
• Same or equivalent key components that affect safety and performance
• Similar risk management outcomes and risk-benefit profile https://www.hsa.gov.sg/medical-devices/registration/grouping/group

3. Allowed Variations within a Group

Permitted differences include:

• Minor variations in size, length, diameter, volume or configuration (within predefined ranges)
• Differences in non-critical materials, colors or aesthetics (non-functional changes)
• Minor software/firmware updates that do not alter core functionality or performance
• Different proprietary names, model numbers or brand names

Significant changes — such as new critical components, altered intended use, or changes affecting safety/performance — disqualify grouping and require separate registration. https://www.hsa.gov.sg/medical-devices/registration/grouping/group

4. Documentation Requirements for Grouped Applications

In addition to standard registration documents, grouped submissions must include:

• A grouping rationale explaining the common design elements and justifying inclusion of all devices
• A comparison table detailing differences across the group and demonstrating equivalence in safety and efficacy
• Representative technical documentation covering the common platform/design (e.g., shared risk analysis, performance testing)
• Individual labeling and instructions for use for each proprietary name or major variant https://www.hsa.gov.sg/medical-devices/registration/grouping/group

5. Registration and Listing Process

• The grouped devices are submitted and registered as one application
• Upon approval, each device with a unique proprietary name or distinct identifier appears as a separate entry on the SMDR
• All devices in the group share the same registration number but are distinctly identified https://www.hsa.gov.sg/medical-devices/registration/grouping/group

6. Post-Registration Obligations

• Adding new devices/variants that meet grouping criteria and share the same proprietary name: submit a Change Notification
• Introducing devices with new proprietary names: requires a new product registration application
• Significant design or performance changes: may trigger re-registration or separate application https://www.hsa.gov.sg/medical-devices/registration/grouping/group

7. Benefits and Practical Considerations

Grouping significantly reduces time, cost and administrative effort for manufacturers offering families of related devices with minor variations. Early consultation with HSA is strongly recommended for complex product families or borderline cases to confirm grouping eligibility and avoid rejection or delays. https://www.hsa.gov.sg/medical-devices/registration/grouping/group

This grouping framework supports efficient market access for related medical devices in Singapore while maintaining rigorous standards for safety and performance. https://www.hsa.gov.sg/medical-devices/registration/grouping/group