Process for Class B Medical Device Registration with HSA in Singapore

The process for registering a Class B medical device with the Health Sciences Authority (HSA) in Singapore is structured and involves several key steps. Below is a detailed guide on the process, required documents, and important considerations for the registration.

1. Determine Device Classification

• Class B devices are considered low to moderate risk medical devices.
• If unsure about the classification of your device, consult the HSA device classification guidelines or reach out to HSA for a classification ruling.

2. Appoint a Local Authorized Representative (LAR)

If the device manufacturer is based outside Singapore, it is mandatory to appoint a Local Authorized Representative (LAR) who is registered with HSA. The LAR will submit the application on behalf of the foreign manufacturer and act as a liaison between HSA and the manufacturer.

• Duties of LAR:
  • Submit the device registration application.
  • Handle communications with HSA.
  • Ensure compliance with local regulations and handle any post-market obligations.

3. Create an Account on the Health Products Regulation System (HPRS)

• HPRS Portal: All applications for medical device registration must be submitted through the Health Products Regulation System (HPRS), HSA's online portal.
  • Create an account: If you do not already have one, visit the HPRS portal and create a user account.
  • Log in: Once your account is set up, log in to the portal to start the registration process.

4. Submit the Application for Class B Registration

Required Information for the Application:

• Device Information:
  • Name and description of the device.
  • Intended use of the device.
  • Manufacturer's details (including company name and address).
  • Risk class and justification for the classification.

Required Documents:

The following documents must be submitted with the application to HSA:

1. Product Registration Form:

   • Complete the online registration form in the HPRS system.

2. Device Description:

   • A detailed description of the device, including its intended purpose, materials, components, and the technology it uses.

3. Declaration of Conformity:

   • A Declaration of Conformity stating that the device complies with relevant regulatory standards (e.g., ISO 13485 for quality management systems, ISO 14971 for risk management).

4. Conformity Assessment:

   • If applicable, provide evidence of regulatory approval from other jurisdictions (e.g., CE Marking, FDA Approval, etc.).

5. Risk Management Report:

   • A risk management report that adheres to the ISO 14971 standard. This report outlines how risks associated with the device have been identified, assessed, and mitigated.

6. Clinical Evaluation Report (if applicable):

   • A clinical evaluation summary if the device is intended for clinical use or requires clinical data to support its safety and effectiveness.

7. Quality Management System (QMS) Certificate:

   • A certificate that confirms compliance with a recognized Quality Management System standard (e.g., ISO 13485). This is mandatory for most medical device manufacturers.

8. Free Sale Certificate:

   • A certificate from the regulatory authority in the country of origin, confirming that the device is legally sold in that country.

9. Labeling and Instructions for Use (IFU):

   • Detailed labeling for the device, which must comply with HSA’s requirements. Labels should include the device name, manufacturer information, warnings, precautions, and instructions for use.

10. Other Supporting Documents: - Depending on the type of device, HSA may require additional documents, such as test reports, performance data, or evidence of biocompatibility testing.

5. Pay the Application Fee

The application fee for Class B medical devices is typically between SGD 1,000 to 2,000, depending on the specifics of the device. Payment is made online via the HPRS portal at the time of submitting the application.

6. HSA Evaluation Process

After submission, HSA will review the application and all supporting documents. The review process typically involves the following steps:

1. Document Verification:
   • HSA will verify that all required documents have been submitted and meet regulatory standards.
2. Technical Evaluation:
   • HSA will assess the safety, performance, and compliance of the device based on the submitted documentation.
3. Risk Assessment:
   • A review of the risk management report and the device’s safety profile will be conducted to ensure that it meets HSA’s safety requirements.

Evaluation Timeframe:

• Class B devices generally take 1 to 3 months to be reviewed by HSA. This timeframe can vary depending on the complexity of the device and the completeness of the submission.

7. Approval and Certificate of Registration

If the application is successful, HSA will issue a Certificate of Registration. This certificate grants you the right to market and sell the device in Singapore.

8. Post-Market Obligations

Once the device is registered, there are ongoing responsibilities that must be fulfilled to maintain compliance:

• Adverse Event Reporting: You must report any adverse events or device-related incidents to HSA.
• Post-Market Surveillance: Continuous monitoring of the device’s performance and safety once it is in the market.
• Recalls (if necessary): If a defect or safety issue is identified, a device recall may be required.
• Periodic Renewals: Depending on the device, HSA may require periodic reviews or updates to maintain the registration.

Important Considerations

1. Regulatory Expertise:

   • Consider engaging with a regulatory consultant or a Local Authorized Representative (LAR) to guide you through the registration process, especially if you are new to the Singaporean medical device market.

2. Device Complexity:

   • Ensure that your device meets all relevant safety and performance standards. If your device involves new technology or has novel risks, additional documentation (e.g., clinical trials, testing reports) may be required.

3. Local Authorized Representative:

   • Foreign manufacturers must appoint a Local Authorized Representative (LAR) who is registered with HSA and will manage the registration process on their behalf.

4. Language and Format Requirements:

   • All documents submitted to HSA should be in English or accompanied by an English translation. The formatting and structure should adhere to HSA’s submission guidelines.

5. Compliance with Local Regulations:

   • It’s essential to comply with Singapore's Medical Device Regulations and to be aware of the HSA’s guidelines for labeling, advertising, and post-market surveillance.

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