To apply for Class C medical device registration with Singapore HSA (Health Sciences Authority), you need to follow these steps:

1. Determine the Classification:

   • Verify if your medical device falls under Class C based on its risk profile. Class C devices are higher-risk and usually require more extensive documentation.

2. Establish a Local Authorized Representative (LAR):

   • If you're a foreign manufacturer, you need to appoint a Local Authorized Representative (LAR) in Singapore to submit the registration on your behalf.

3. Prepare the Necessary Documentation:

   • Device Description: Provide a detailed description of the device, including its intended use, indications, and classification.
   • Manufacturing Information: Submit details about the manufacturing process, quality management systems (e.g., ISO 13485 certification), and the facility.
   • Risk Management: Provide a risk analysis report following ISO 14971 standards.
   • Clinical Evidence: Submit clinical data supporting the safety and performance of the device. This could include clinical trials or equivalence data.
   • Labelling and Instructions: Include the product labeling, instructions for use, and any other necessary documents in accordance with HSA's requirements.
   • Declaration of Conformity: Provide a declaration that the device complies with relevant regulatory standards.

4. Prepare the Application in the HSA's Online System:

   • Create an account on HSA’s online registration system (e.g., the Medical Device Branch portal).
   • Complete the application by uploading the necessary documents and information.

5. Submit the Application:

   • Submit the application and pay the associated fees. The HSA will review the submission for completeness and compliance with the regulatory requirements.

6. Review by HSA:

   • HSA will evaluate the documentation and may request additional information. The evaluation process may include an inspection of the manufacturing site and a review of clinical data.

7. Approval and Registration:

   • If the application is successful, HSA will issue the registration for the medical device, which will be valid for 5 years.

8. Post-Market Requirements:

   • After approval, the device is subject to post-market surveillance. You will need to report any adverse events or safety concerns and keep HSA updated on any changes to the device or its manufacturing process.

If you need more details about each step or specific requirements, feel free to ask!