Singapore HSA Full Registration Requirements for Class B Medical Devices

1. Overview of Class B Full Registration

Class B medical devices in Singapore, classified as low to moderate risk, require full registration before they can be imported, manufactured, or supplied. This pathway involves submission of a comprehensive technical dossier by the Singapore Authorized Representative (AR) to the Health Sciences Authority (HSA) for detailed evaluation of safety, quality, and performance. Upon successful review, HSA issues a registration approval, allowing the device to be listed on the Singapore Medical Device Register (SMDR). https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration

2. Who Must Apply

The Singapore Authorized Representative (AR) is responsible for submitting the full registration application for Class B devices. Foreign manufacturers must appoint a locally registered AR who acts as the point of contact with HSA and holds responsibilities for post-market surveillance and compliance. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration

3. Required Documentation

The full technical dossier for Class B devices must demonstrate conformity to the Essential Principles of Safety and Performance and include:

• Device description, intended use, and indications
• Design and manufacturing information
• Risk management file per ISO 14971
• Performance testing and validation data
• Clinical evidence (where applicable)
• Labeling, instructions for use, and promotional materials
• Quality management system evidence (ISO 13485 certification preferred)
• Declaration of Conformity
• Free Sale Certificate or equivalent from country of origin https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration

4. Conformity Assessment and Evaluation

HSA evaluates the submission to verify:

• Compliance with Essential Principles
• Adequacy of risk management and mitigation measures
• Validity of performance claims through testing data
• Appropriateness of labeling and instructions

For Class B devices, evaluation may involve abridged or full review depending on prior approvals from reference agencies (e.g., US FDA, EU Notified Body, TGA Australia). https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration

5. Timeline and Fees

• Target timeline: Approximately 120 working days for full evaluation (may vary based on dossier quality and prior approvals)
• Official fees are charged for application processing and registration issuance
• Priority review may be available for certain devices under specific schemes https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration

6. Post-Registration Obligations

After approval:

• Maintain ongoing post-market surveillance and vigilance reporting
• Notify HSA of changes to the device (via Change Notification or new application as required)
• Comply with labeling, advertising, and distribution regulations
• Renew registration periodically (typically every 5 years) https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration

7. Practical Considerations

Class B full registration ensures appropriate oversight for moderate-risk devices while leveraging prior approvals from reference agencies to potentially shorten review times. Manufacturers should prepare high-quality, complete dossiers and engage with their AR early to avoid delays or deficiencies during HSA evaluation. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration

This pathway balances timely market access with rigorous safety and performance assurance for Class B medical devices in Singapore. https://www.hsa.gov.sg/medical-devices/registration/guides/class-b-full-registration