Singapore HSA Abridged Registration Pathway for Class D Medical Devices

1. Overview of Abridged Registration

The abridged registration pathway applies to 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 leverages prior comprehensive evaluations to streamline the submission, reduce the extent of the technical dossier, and shorten the HSA review timeline compared to full registration, while maintaining rigorous safety, efficacy, and quality standards for high-risk devices in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-abridged-registration

2. Eligibility Criteria

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

• Valid current approval from at least one 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-abridged-registration

3. Acceptable Reference Agencies

HSA accepts approvals from the following major stringent authorities for abridged registration of Class D devices:

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

4. Required Documentation

Abridged submissions require a reduced dossier compared to full registration, typically including:

• Proof of current valid reference agency approval (certificate, 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 required)

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

5. Review Process and Timeline

HSA performs a targeted evaluation, focusing on:

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

The target review timeline is substantially shorter than full registration, typically around 150–180 working days, depending on 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-abridged-registration

6. Post-Registration Obligations

After approval:

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

7. Benefits and Practical Considerations

The abridged pathway significantly reduces preparation time and regulatory burden for high-risk Class D devices already thoroughly assessed by stringent reference authorities, promoting timely patient access while upholding the highest safety standards. Manufacturers must ensure perfect alignment between versions and collaborate closely with their Authorized Representative to prepare precise submissions. Early engagement with HSA is recommended for complex high-risk devices or borderline cases. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-abridged-registration

This route balances efficient market entry with robust regulatory oversight for high-risk medical devices in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-abridged-registration