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January 17, 2026
Approximately 5 minutes
Singapore HSA Abridged Registration for Class D Medicinal Product Medical Devices
Singapore HSA Abridged Registration for Class D Medicinal Product Medical Devices
1. Overview of Abridged Registration
The abridged registration pathway applies to Class D medical devices incorporating a medicinal substance as an integral component (drug-device combinations). Devices with valid approval from designated stringent reference agencies may qualify for reduced documentation and a more focused HSA evaluation compared to full registration, while still ensuring comprehensive oversight of both device and medicinal aspects. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration
2. Eligibility Criteria
Class D medicinal product 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, Australia TGA ARTG with conformity assessment, Japan PMDA approval, Canada Health Canada Class III/IV licence)
- The Singapore version is identical in design, intended use, specifications, medicinal substance, dosage, and labeling to the reference-approved version
- No significant post-approval changes affecting safety, performance, or intended use
- The medicinal substance is ancillary to the principal mode of action of the device (primary mode remains physical/mechanical) https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration
3. Acceptable Reference Agencies
HSA accepts approvals from the following authorities for abridged registration of Class D medicinal product devices:
- United States FDA: Premarket Approval (PMA)
- 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-d-medicinal-products-abridged-registration
4. Required Documentation
Abridged submissions require a reduced dossier, typically including:
- Proof of current reference agency approval for the combination product
- 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
- Summary of medicinal substance quality, safety, and efficacy data (if not fully covered by reference approval)
Detailed technical data on the medicinal component may be reduced if adequately addressed by the reference approval. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration
5. Review Process and Timeline
HSA conducts a targeted evaluation focusing on:
- Validity and scope of reference approval for the combination product
- Identicality of the Singapore version
- Compliance with local requirements for labeling, distribution, and pharmacovigilance
Target review timeline is shorter than full registration, typically around 180 working days. Approved products 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-medicinal-products-abridged-registration
6. Post-Registration Obligations
After approval:
- Implement enhanced post-market surveillance for both device and medicinal components
- Report adverse events, quality issues, and vigilance matters promptly
- Notify HSA of any changes affecting the device or medicinal substance
- Comply with combined device and pharmaceutical vigilance requirements
- Renew registration periodically https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration
7. Benefits and Practical Considerations
The abridged pathway reduces regulatory burden for complex drug-device combinations already rigorously assessed by reference authorities, enabling faster patient access while preserving high safety standards. Manufacturers must ensure absolute identicality and strong collaboration between device and pharmaceutical teams. Pre-submission consultation with HSA is recommended for borderline cases. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration
This route balances efficiency with stringent oversight for high-risk combination products in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration
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