Singapore HSA Abridged Registration Pathway for Class C Medical Devices

1. Overview of Abridged Registration

The abridged registration pathway is available for Class C medical devices (moderate to high risk) that have obtained valid approval from specified reference regulatory authorities. This route relies on prior assessments to streamline the submission process, reduce the required technical dossier, and shorten HSA review timelines compared to full registration, facilitating efficient market access in Singapore while maintaining rigorous safety and efficacy standards. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-abridged-registration

2. Eligibility Criteria

Class C 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 or 510(k) with clinical data, EU CE marking under MDR, Australia TGA ARTG with conformity assessment, Japan PMDA approval, Canada Health Canada Class III or IV licence)
• The Singapore version is identical in design, intended use, specifications, materials, and labeling to the reference-approved device
• No significant post-approval changes have occurred that impact safety, performance, or intended use
• The device falls within Class C under Singapore's risk classification rules https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-abridged-registration

3. Acceptable Reference Agencies and Approvals

HSA accepts approvals from the following stringent authorities for abridged registration:

• United States FDA: Premarket Approval (PMA) or 510(k) with substantial clinical data
• European Union: CE marking under Medical Device Regulation (MDR)
• 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-c-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 of 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)

Full technical data (detailed risk files, extensive performance testing, comprehensive clinical reports) are generally not required if covered by the reference approval. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-abridged-registration

5. Review Process and Timeline

HSA performs a focused evaluation, verifying:

• Validity and scope of the reference approval
• Identicality of the Singapore device to the approved version
• Compliance with local labeling, advertising, and regulatory requirements

Target review timeline is shorter than full registration, typically around 90–120 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-c-abridged-registration

6. Post-Registration Obligations

After approval:

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

7. Benefits and Practical Considerations

The abridged pathway significantly reduces preparation effort and time to market for Class C devices already evaluated by rigorous reference authorities, while preserving high regulatory standards. Manufacturers must ensure strict identicality between versions and collaborate closely with their Authorized Representative to avoid deficiencies. Early consultation with HSA is recommended for complex cases or recent reference changes. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-abridged-registration

This route supports timely availability of safe and effective moderate-to-high risk medical devices in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-abridged-registration