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), which is the official online portal for managing regulatory submissions to HSA.

Steps to Apply:

1. Create an Account on HPRS:

   • If you do not already have an account, you will need to create a new user account on the HPRS portal.
   • Visit the HPRS portal: HPRS Portal
   • Navigate to the "Account Registration" section to set up your account.

2. Log in to HPRS:

   • Once your account is set up, log in to the HPRS system using your credentials.

3. Submit the Application:

   • After logging in, access the medical device registration section in the HPRS system.
   • Select "Class B Medical Device" from the available categories.
   • Complete the online application form by providing information such as the device name, intended use, manufacturer details, and more.
   • Upload the required documents: You will need to upload all the necessary supporting documentation (e.g., product description, risk management report, conformity assessment, quality management system certificate, etc.).

4. Pay the Registration Fee:

   • After filling out the application form and uploading the documents, you will be prompted to pay the registration fee online through the HPRS system. The fee for Class B medical device registration is typically between SGD 1,000 to 2,000, depending on the specifics of the device.

5. Submit the Application:

   • Once all the details are complete and the fee has been paid, submit the application for evaluation by HSA.

Key HPRS Portal Links:

• HPRS Portal (Official site): https://www.hsa.gov.sg
  • Under the “Regulation of Health Products” section, you will find links to the Health Products Regulation System (HPRS).
• HPRS User Guide: HSA provides a comprehensive user guide on how to submit medical device registration applications through the HPRS portal. You can find this guide on the portal or in HSA's guidance documents section.

For Foreign Manufacturers:

• If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) in Singapore to act on your behalf. The LAR will be responsible for submitting the application, liaising with HSA, and managing regulatory obligations.
  • Find a Local Authorized Representative: This can be done by contacting regulatory consultancies or service providers in Singapore who offer LAR services.

Additional Resources:

• HSA's Medical Device Regulations Page: Visit HSA's Medical Device Regulations for more details on the application process, requirements, and guidelines.
• HSA’s Contact Information: If you need assistance, you can contact HSA directly at their customer service for further guidance.

By using the HPRS portal, you can complete the Class B medical device registration application process in Singapore. Make sure all your documents are in order to ensure a smooth submission and approval process.