Singapore HSA Full Registration Requirements for Class D Medical Devices

1. Overview of Class D Full Registration

Class D medical devices, classified as high risk in Singapore (e.g., implantable devices, active implantable devices, life-supporting devices), require full registration prior to import, manufacture, or supply. This pathway demands submission of a comprehensive technical dossier by the Singapore Authorized Representative (AR) to the Health Sciences Authority (HSA) for in-depth evaluation of safety, efficacy, quality, and risk-benefit profile. Successful review results in registration approval and individual listing on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration

2. Who Must Apply

The Singapore Authorized Representative (AR) is responsible for submitting the full registration application for Class D devices. Foreign manufacturers must appoint a locally registered AR, who serves as the primary point of contact with HSA and holds ongoing responsibilities for post-market surveillance, vigilance reporting, and regulatory compliance. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration

3. Required Documentation

The full technical dossier for Class D devices must demonstrate conformity to the Essential Principles of Safety and Performance and typically includes:

• Detailed device description, intended use, indications, and contraindications
• Comprehensive design specifications, manufacturing process, and materials information
• Extensive risk management file per ISO 14971, including risk-benefit analysis
• Robust performance testing, validation, and verification data
• Clinical evaluation report with substantial clinical evidence (clinical investigations often required)
• Labeling, instructions for use, and promotional materials
• Quality management system documentation (ISO 13485 certification mandatory)
• Declaration of Conformity
• Free Sale Certificate or equivalent from country of origin https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration

4. Conformity Assessment and Review Focus

HSA conducts a thorough and stringent evaluation, with particular emphasis on:

• Full compliance with Essential Principles of Safety and Performance
• Adequacy, effectiveness, and implementation of risk management measures
• Strength, relevance, and quality of clinical evidence supporting safety and performance claims
• Validity of performance data and testing under real-world conditions
• Appropriateness and clarity of labeling, instructions, and user information

Class D devices generally require robust clinical data, and prior approvals from reference agencies may influence the review but do not qualify for abridged or expedited routes. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration

5. Timeline and Fees

• Target timeline: Approximately 210–270 working days for full evaluation (may vary based on dossier complexity, clinical data quality, and submission completeness)
• Official application and registration fees apply
• Priority or expedited review is not typically available for standard Class D submissions https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration

6. Post-Registration Obligations

Upon approval:

• Implement rigorous ongoing post-market surveillance, vigilance reporting, and field safety corrective actions
• Submit change notifications or new applications for any modifications affecting safety, performance, or intended use
• Comply with Singapore-specific requirements for distribution, advertising, traceability, and periodic reporting
• Renew registration periodically (typically every 5 years) https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration

7. Practical Considerations

Full registration for Class D devices reflects their high-risk nature and ensures the highest level of regulatory scrutiny. Manufacturers should prepare exceptionally thorough dossiers with strong clinical and performance evidence, and engage early with their AR to address potential questions or deficiencies. Reference agency approvals can assist in demonstrating conformity but do not substitute for HSA's independent evaluation. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration

This pathway provides robust protection for patients while enabling safe and effective high-risk medical devices to reach the Singapore market. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-full-registration