To apply for D-class medical device registration in Singapore with the Health Sciences Authority (HSA), you need to follow the official procedures and apply through the Medical Device Information and Communication System (MEDICS) portal. Here is a step-by-step guide on how to apply for D-class medical device registration and where to apply:

Where to Apply:

The application for D-class medical device registration is done through the HSA's MEDICS portal, which is the online system used to manage medical device registrations in Singapore.

• MEDICS Portal: HSA MEDICS Portal
• User Registration: If you are not already registered, you need to create an account with MEDICS.

Steps to Apply for D-Class Medical Device Registration

1. Appoint a Local Authorized Representative (if applicable)

• For Foreign Manufacturers: If you are a manufacturer based outside Singapore, you must appoint a Local Authorized Representative (AR) based in Singapore. The AR will submit the registration on your behalf and handle communication with HSA.
• AR Role: The AR will ensure that the device meets all HSA regulations, submit the necessary documentation, and handle post-market surveillance obligations.

2. Prepare Required Documents

Before starting the application, ensure you have all the required documentation ready for submission. This includes:

• Device Description
• Clinical Data and Clinical Evaluation Report
• Risk Management Plan and Risk Analysis Report
• Manufacturing Information (GMP compliance, process details)
• ISO 13485 Certification (Quality Management System)
• Labeling and Instructions for Use (IFU)
• Certificate of Free Sale (CFS) (if applicable)
• Authorized Representative (AR) Appointment Letter (if applicable)
• Completed Application Form
• Payment Receipt for registration fees

3. Access the MEDICS Portal

• Go to the HSA MEDICS Portal: HSA MEDICS Portal.
• Log in: Use your credentials (or create an account if you don’t have one yet).
• Choose the Application Type: Select D-Class Registration as the type of device you are registering.

4. Complete the Application Form

• Fill in the required details: This includes the device details, manufacturer information, and the Local Authorized Representative (AR) details (if applicable).
• Upload the documents: You will need to upload all the required documents mentioned earlier in the correct format (usually PDF).

5. Pay the Registration Fee

• The application requires payment of a registration fee. For D-class devices, the fee is approximately SGD 1,070. The fee must be paid at the time of submission.
• Payment Methods: You can pay via credit card or other available methods on the MEDICS portal.

6. Submit the Application

• After completing the form and uploading the necessary documents, review the information and submit the application through the MEDICS portal.

7. HSA Review and Evaluation

• HSA will review the application and may request additional information or clarification. The review will include checking compliance with clinical data, risk management, and manufacturing practices.
• Inspection: HSA may also perform a Good Manufacturing Practice (GMP) inspection at the manufacturing facility.

8. Respond to Requests for Additional Information

• If HSA requests any further documents or clarifications, you must respond promptly to avoid delays in the registration process.

9. HSA Approval and Issuance of Certificate of Registration (COR)

• Upon successful evaluation, HSA will approve the device and issue a Certificate of Registration (COR). This certifies that your D-class medical device is authorized for sale in Singapore.
• The COR will be valid for 5 years, after which it will need to be renewed.

10. Post-Market Surveillance

• Once the device is registered, there are post-market obligations such as reporting adverse events, conducting device recalls (if necessary), and ensuring continuous compliance with HSA regulations.

Key Points to Remember:

• Apply through MEDICS: All D-class medical device registrations are processed through the HSA’s MEDICS portal.
• Local Authorized Representative: If you are a foreign manufacturer, you must appoint a Local Authorized Representative in Singapore.
• Prepare Documents in Advance: Ensure that all required documents are ready before starting the application process.
• Fees: The registration fee for D-class devices is approximately SGD 1,070.
• Clinical and Risk Management Data: D-class devices require substantial clinical evidence and a comprehensive risk management plan.

By following these steps and submitting the necessary documents, you can successfully apply for D-class medical device registration with HSA in Singapore.

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