To apply for D-class medical device registration in Singapore with the Health Sciences Authority (HSA), you will need to use the Medical Device Information and Communication System (MEDICS), which is HSA's official online platform for medical device registration.

Here are the steps to apply:

1. Access the MEDICS Portal

• The application is submitted through the MEDICS portal.
• Website: You can access the portal at the following link: HSA MEDICS Portal
  • If you're a first-time user, you will need to create an account to log in and start the application process.

2. Create an Account / Login

• For local manufacturers: You can register directly in MEDICS by creating an account.
• For foreign manufacturers: You must appoint a Local Authorized Representative (AR) in Singapore to submit the application on your behalf.
  • The AR will handle the registration process and act as the point of contact with HSA.

3. Prepare and Submit the Application

• Once logged in, you will need to complete the application form and upload the necessary documents, such as:
  • Device description
  • Clinical data and risk management plans
  • Manufacturing details
  • QMS certification (ISO 13485, etc.)
  • Labeling and instructions for use
  • Certificate of Free Sale (if applicable)
• Pay the registration fee via the portal (typically SGD 1,070 for D-class devices).

4. Track Application Status

• After submission, you can track the status of your application through the MEDICS portal.
• You will receive updates if HSA requires any additional information or clarifications.

5. Communication with HSA

• If needed, the AR (or local manufacturer) must be responsive to any requests for further documentation or clarification from HSA during the review process.

Key Notes:

• Local Authorized Representative: If you are a foreign manufacturer, ensure you have appointed a qualified Local AR in Singapore to submit the application on your behalf and manage all communications with HSA.
• Additional Fees: Be aware that additional inspection fees may apply if HSA requires a Good Manufacturing Practice (GMP) inspection or other evaluations.

By following the above steps and using the MEDICS portal, you can apply for the registration of your D-class medical device in Singapore through HSA.