Singapore HSA Full Registration Requirements for Class C Medical Devices

1. Overview of Class C Full Registration

Class C medical devices, classified as moderate to high risk in Singapore, require full registration prior to import, manufacture, or supply. This pathway involves submission of a complete technical dossier by the Singapore Authorized Representative (AR) to the Health Sciences Authority (HSA) for in-depth evaluation of safety, efficacy, and quality. Successful review results in registration approval and listing on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-full-registration

2. Who Must Apply

The Singapore Authorized Representative (AR) is solely responsible for submitting the full registration application for Class C devices. Foreign manufacturers must appoint a locally registered AR, who serves as the primary liaison with HSA and bears ongoing responsibilities for post-market compliance and vigilance. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-full-registration

3. Required Documentation

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

• Detailed device description, intended use, and indications
• Design specifications, manufacturing process, and materials information
• Comprehensive risk management file per ISO 14971
• Performance testing, validation, and verification data
• Clinical evaluation report and supporting clinical evidence
• Labeling, instructions for use, and promotional materials
• Quality management system documentation (ISO 13485 certification strongly preferred)
• Declaration of Conformity
• Free Sale Certificate or equivalent from country of origin https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-full-registration

4. Conformity Assessment and Review Focus

HSA conducts a rigorous evaluation, focusing on:

• Compliance with Essential Principles of Safety and Performance
• Adequacy and effectiveness of risk management measures
• Validity of performance claims supported by robust testing data
• Strength and relevance of clinical evidence for the intended use
• Appropriateness of labeling, instructions, and user information

For Class C devices, clinical data requirements are more substantial than for lower classes, and prior approvals from reference agencies may influence the depth of review but do not automatically qualify for abridged routes. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-full-registration

5. Timeline and Fees

• Target timeline: Approximately 180–210 working days for full evaluation (may vary based on dossier completeness, complexity, and reference approvals)
• Official application and registration fees apply
• Priority or expedited review may be available under specific schemes or for high-priority devices https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-full-registration

6. Post-Registration Obligations

Upon approval:

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

7. Practical Considerations

Full registration for Class C devices ensures thorough oversight commensurate with their risk level. Manufacturers should prepare high-quality, well-organized dossiers with strong clinical and performance evidence, and engage early with their AR to address potential questions. Leveraging reference agency approvals can help streamline certain aspects of the review. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-full-registration

This pathway balances patient safety with appropriate regulatory scrutiny for moderate-to-high risk medical devices in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-full-registration