Singapore HSA Immediate Registration Route for Class B Medical Devices

1. Purpose and Scope

The immediate registration route is designed for low-risk Class B medical devices that already hold valid approval from specified stringent regulatory authorities. This pathway minimizes regulatory burden and accelerates market access in Singapore by relying heavily on prior assessments from reference agencies, requiring only notification and basic verification by HSA. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-immediate-registration

2. Eligibility Criteria

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

• Current valid approval from an acceptable reference agency (US FDA 510(k), EU CE marking under MDD/AIMDD/MDR, Australia TGA ARTG, Japan PMDA, Canada Health Canada Class II)
• Device intended for Singapore is identical in design, intended use, specifications, and labeling to the reference-approved version
• No significant changes affecting safety, performance, or intended use have occurred since reference approval
• Device falls within the scope of Class B and meets Singapore's classification rules https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-immediate-registration

3. Acceptable Reference Approvals

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

• United States FDA: 510(k) clearance
• European Union: CE marking (MDD, AIMDD, or MDR)
• Australia TGA: Inclusion in the Australian Register of Therapeutic Goods (ARTG)
• Japan PMDA: Approval
• Health Canada: Class II Medical Device Licence https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-immediate-registration

4. Required Submission Documents

The Singapore Authorized Representative must submit:

• Proof of current reference agency approval (certificate or clearance letter)
• Device description 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 requested)

No full technical dossier or detailed performance data is required. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-immediate-registration

5. Process and Timeline

• Submission is made via the HSA online portal
• HSA performs administrative verification of documents and reference approval validity
• Upon satisfactory review (typically very quick, often within days to weeks), the device is granted immediate registration
• Registered devices are listed on the Singapore Medical Device Register (SMDR) with a registration number https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-immediate-registration

6. Post-Registration Requirements

After registration:

• Maintain 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-b-immediate-registration

7. Benefits and Practical Considerations

Immediate registration significantly shortens time to market for eligible Class B devices already approved by rigorous authorities, reducing duplication of effort while upholding safety standards. Manufacturers should ensure perfect alignment between the Singapore and reference versions and work closely with their Authorized Representative to prepare accurate submissions. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-immediate-registration

This pathway supports rapid availability of low-risk medical devices in Singapore without compromising regulatory oversight. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-immediate-registration