Singapore HSA Expedited Registration Pathway for Class D Medical Devices

1. Overview and Purpose

The expedited registration pathway is available for Class D medical devices (high risk, e.g., implantable, active implantable, life-supporting) that have valid approval from specified stringent reference regulatory authorities. This route accelerates market access in Singapore by relying on prior rigorous assessments, resulting in a shorter review timeline and focused evaluation compared to full registration, while ensuring equivalent high standards of safety, efficacy, and quality for high-risk devices. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration

2. Eligibility Criteria

Class D devices qualify for expedited registration if they meet all of the following:

• Valid current approval from an acceptable reference agency (US FDA PMA, EU CE marking under MDR with full clinical evaluation, Australia TGA ARTG with conformity assessment, Japan PMDA approval, Canada Health Canada Class III/IV licence)
• The device intended for supply in Singapore is identical in design, intended use, specifications, materials, labeling, and all critical aspects to the reference-approved version
• No significant post-approval changes have occurred that could affect safety, performance, or intended use
• The device is classified as Class D under Singapore's risk-based classification rules https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration

3. Acceptable Reference Agencies

HSA recognizes approvals from the following stringent authorities for expedited registration of Class D devices:

• United States FDA: Premarket Approval (PMA)
• European Union: CE marking under Medical Device Regulation (MDR) with comprehensive clinical evaluation
• Australia TGA: Inclusion in ARTG with conformity assessment
• Japan PMDA: Approval
• Health Canada: Class III or IV Medical Device Licence https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration

4. Required Documentation

Expedited submissions require a streamlined dossier, typically including:

• Proof of current valid reference agency approval (certificate or approval letter)
• Device description and attestation confirming identicality to the reference-approved version
• Singapore-specific labeling and instructions for use
• Declaration of Conformity
• Appointment of Singapore Authorized Representative
• Free Sale Certificate or equivalent (if requested)

Extensive technical data (detailed risk management, full performance testing, comprehensive clinical reports) are generally not required if adequately covered by the reference approval. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration

5. Review Process and Timeline

HSA conducts a targeted and expedited evaluation, focusing on:

• Confirmation of reference approval validity, scope, and relevance
• Verification of identicality between the Singapore and reference-approved device
• Compliance with local labeling, advertising, distribution, and regulatory requirements

The target review timeline is significantly shorter than full registration, typically around 180 working days, subject to submission quality and reference agency type. Approved devices receive a registration number and are listed on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration

6. Post-Registration Obligations

After approval:

• Maintain rigorous ongoing post-market surveillance and vigilance reporting to HSA
• Submit change notifications or new applications for modifications affecting safety, performance, or intended use
• Comply with Singapore-specific requirements for distribution, promotion, traceability, and periodic reporting
• Renew registration periodically (usually every 5 years) https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration

7. Benefits and Practical Considerations

The expedited pathway substantially reduces time to market for high-risk Class D devices already vetted by high-standard reference authorities, minimizing duplication while preserving robust regulatory oversight. Manufacturers must ensure complete alignment between versions and work closely with their Authorized Representative to prepare accurate submissions. Pre-submission consultation with HSA is advisable for complex high-risk devices or borderline eligibility. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration

This route facilitates timely access to safe and effective high-risk medical devices in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-expedited-registration