To apply for Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, you must submit your application through the Health Products Regulation System (HPRS). This is the official online platform for managing regulatory submissions to HSA.

Steps to Apply for Class B Medical Device Registration

1. Create an Account on HPRS

• If you do not already have one, you will need to create an account on the HPRS portal.
• To create an account, visit the HPRS portal at https://www.hsa.gov.sg and follow the instructions to register.

2. Appoint a Local Authorized Representative (LAR)

• If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) based in Singapore to submit the application on your behalf.
• The LAR is responsible for managing the registration process and acting as the liaison with HSA.

3. Log in to HPRS

• Once your account is set up, log in to the HPRS portal with your username and password.

4. Complete the Online Application

• In HPRS, navigate to the medical device registration section.
• Select the appropriate registration type (e.g., Class B Medical Device).
• Fill out the online application form, providing details such as:
  • Device name and description.
  • Intended use.
  • Manufacturer's information (name, address, etc.).
  • Risk classification and justification.
• Upload the Required Documents (such as device description, conformity assessment, risk management report, clinical evaluation report, quality management system certificate, etc.). The list of required documents can be found in the HSA’s Medical Device Registration Guidelines.

5. Pay the Registration Fee

• The registration fee for Class B devices is typically between SGD 1,000 and SGD 2,000. The exact fee depends on the specifics of the device.
• Payment can be made via the HPRS portal using available online payment methods.

6. Submit the Application

• After completing the application form and uploading the required documents, submit the application for evaluation by HSA.

7. HSA Review and Evaluation

• HSA will review the application and assess whether the device meets the safety and performance standards required for market authorization.
• The review process typically takes 1 to 3 months, depending on the complexity of the device and the completeness of the submission.

8. Obtain Certificate of Registration

• If the application is successful, HSA will issue a Certificate of Registration, allowing the device to be legally marketed and sold in Singapore.

Where to Apply:

• Health Products Regulation System (HPRS): This is the official online portal where all medical device registrations must be submitted.
  • HPRS Portal: https://www.hsa.gov.sg
    • Once on the HSA website, navigate to the “Regulation of Health Products” section, and you will find a link to the HPRS system for medical device registration.

Additional Considerations:

• Local Authorized Representative (LAR): If you are a foreign manufacturer, make sure to appoint an HSA-registered Local Authorized Representative (LAR). The LAR will be responsible for submitting the registration on your behalf and ensuring compliance with local regulatory requirements.

• Compliance with Local Regulations: Ensure your device complies with Singapore's Medical Device Regulations and HSA’s guidelines, including labeling, advertising, and post-market surveillance requirements.

• Supporting Documents: Be thorough when preparing the required documents. Incomplete or incorrect documentation can lead to delays in the registration process.

By following these steps, you can successfully submit an application for Class B medical device registration with HSA in Singapore.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn