Singapore HSA Device Family Grouping for Registration

1. Purpose of Family Grouping

HSA permits medical devices to be grouped as a 'family' to facilitate efficient registration when multiple models share common characteristics. This approach allows a single product registration application for related devices, reducing administrative burden while ensuring all variants meet safety and performance requirements. Each family is registered under one application, with individual models listed separately if they have distinct proprietary names. https://www.hsa.gov.sg/medical-devices/registration/grouping/family

2. Eligibility Criteria for Family Grouping

Devices qualify for family grouping if they satisfy all the following conditions:

• Same product owner / manufacturer
• Same risk classification (all Class A, B, C, or D)
• Same intended purpose and patient population
• Same fundamental design, technology, and operating principle
• Same or equivalent key components affecting safety and performance
• Similar risk management outcomes and risk-benefit profile https://www.hsa.gov.sg/medical-devices/registration/grouping/family

3. Allowed Variants within a Family

Limited variations are permitted within a family registration:

• Differences in size, length, diameter, or volume (e.g., catheter lengths)
• Variations in non-critical materials or colors (non-functional changes)
• Minor software or firmware updates that do not alter core functionality
• Different proprietary or brand names (each listed separately on SMDR)

Significant differences (e.g., changes in critical materials, energy source, or intended use) disqualify grouping and require separate registrations. https://www.hsa.gov.sg/medical-devices/registration/grouping/family

4. Documentation Requirements

Family grouping applications must include:

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

5. Registration and Listing Process

• The device family is submitted and registered as one application
• Upon approval, models with unique proprietary names are listed separately on the Singapore Medical Device Register (SMDR)
• All models share the same registration number but are distinctly identified https://www.hsa.gov.sg/medical-devices/registration/grouping/family

6. Post-Registration Obligations

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

7. Benefits and Practical Considerations

Family grouping streamlines registration for related device models, lowering time and cost for manufacturers offering product lines with minor variations. Manufacturers should consult HSA early for complex families or borderline cases to confirm eligibility and avoid rejection or delays. https://www.hsa.gov.sg/medical-devices/registration/grouping/family

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