Singapore HSA Immediate Registration Route for Class C Medical Devices

1. Purpose and Scope

The immediate registration route is intended for selected Class C medical devices (moderate to high risk) that already hold valid approval from stringent reference regulatory authorities. This pathway enables the fastest possible market access in Singapore by relying almost entirely on prior evaluations, requiring only administrative notification and basic verification by HSA, with no in-depth technical review. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-immediate-registration

2. Eligibility Criteria

Class C devices qualify for immediate registration if they satisfy all of the following:

• Current valid 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 Singapore is identical in design, intended use, specifications, materials, and labeling to the reference-approved version
• No significant changes affecting safety, performance, or intended use have occurred since reference approval
• The device falls within the scope of Class C under Singapore's risk classification rules https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-immediate-registration

3. Acceptable Reference Approvals

HSA recognizes approvals from the following authorities for immediate registration eligibility:

• 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-c-immediate-registration

4. Required Submission Documents

The Singapore Authorized Representative must submit:

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

No full technical dossier, risk management file, performance testing, or clinical data submission is required. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-immediate-registration

5. Process and Timeline

• Submission via the HSA online portal
• HSA conducts administrative verification of documents and reference approval validity
• Upon satisfactory check (typically very rapid, often within days to a few weeks), immediate registration is granted
• Registered 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-immediate-registration

6. Post-Registration Obligations

After registration:

• Implement ongoing post-market surveillance and report adverse events to HSA
• Notify HSA of any changes via appropriate variation or new registration process
• Comply with Singapore regulations on distribution, advertising, and vigilance
• Registration remains valid as long as reference approval is maintained and no major changes occur https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-immediate-registration

7. Benefits and Practical Considerations

Immediate registration provides the quickest route to market for eligible Class C devices already approved by high-standard authorities, significantly reducing time and effort while upholding safety through reliance on reference assessments. Manufacturers must ensure strict identicality and accurate documentation. Collaboration with the Authorized Representative is essential to avoid delays. https://www.hsa.gov.sg/medical-devices/registration/guides/class-c-immediate-registration

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