Singapore HSA Abridged Registration Pathway for Class B Medical Devices

1. Overview of Abridged Registration

The abridged registration pathway applies to Class B medical devices that have been approved by designated reference regulatory agencies. This route leverages prior evaluations to reduce the technical dossier requirements and accelerate HSA review, facilitating faster market access in Singapore while ensuring equivalent safety, quality, and performance standards. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration

2. Eligibility Criteria

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

• Device has current approval from at least one acceptable reference agency (e.g., US FDA 510(k) clearance, EU CE marking under MDD/AIMDD/MDR, Australia TGA ARTG inclusion, Japan PMDA approval, Canada Health Canada Class II licence)
• Approval from the reference agency is still valid at the time of HSA submission
• The device intended for supply in Singapore is identical in design, intended use, and labeling to the version approved by the reference agency
• No significant post-approval changes have been made that affect safety or performance https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration

3. Acceptable Reference Agencies

HSA accepts approvals from the following major regulatory authorities for abridged registration:

• United States Food and Drug Administration (FDA) – 510(k) clearance or De Novo classification
• European Union – CE marking under Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD), or Medical Device Regulation (MDR)
• Australia Therapeutic Goods Administration (TGA) – ARTG inclusion
• Japan Pharmaceuticals and Medical Devices Agency (PMDA) – Approval
• Health Canada – Class II Medical Device Licence https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration

4. Required Documentation

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

• Proof of current reference agency approval (e.g., certificate, clearance letter)
• Device description and comparison confirming identicality to the approved version
• Labeling and instructions for use (Singapore-specific requirements)
• Declaration of Conformity
• Singapore Authorized Representative appointment
• Free Sale Certificate or equivalent (if required)

Full technical data (e.g., detailed risk management, performance testing) is generally not required if covered by the reference approval. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration

5. Review Process and Timeline

HSA conducts a targeted evaluation focused on:

• Verification of reference approval validity and scope
• Conformity of the Singapore version to the approved device
• Compliance with local labeling and regulatory requirements

Target review timeline is significantly shorter than full registration, typically around 60 working days, depending on submission quality. Upon approval, the device receives a registration number and is listed on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration

6. Post-Registration Obligations

Post-approval requirements include:

• Ongoing post-market surveillance and adverse event reporting
• Notification of changes to HSA (major changes may require new application)
• Compliance with Singapore-specific regulations on distribution, advertising, and vigilance
• Periodic registration renewal https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration

7. Benefits and Practical Considerations

The abridged pathway substantially reduces preparation time and regulatory burden for devices already vetted by stringent reference agencies, promoting timely access to safe and effective Class B medical devices in Singapore. Manufacturers should ensure identicality between the Singapore and reference-approved versions and consult HSA or their Authorized Representative for borderline cases or recent reference changes. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration

This route supports efficient market entry while upholding high regulatory standards for moderate-risk devices. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-abridged-registration