To apply for Class C medical device registration with Singapore's Health Sciences Authority (HSA), you will need to follow a specific process and apply through HSA's Medical Device Registration (MDR) portal. Below is a step-by-step guide on how to apply for Class C medical device registration and where to apply:

How to Apply for Class C Medical Device Registration with HSA:

1. Visit the HSA Medical Device Registration Portal:

   • The primary platform for submitting medical device applications is the HSA MDR portal.
   • You can access the portal here: HSA Medical Device Registration Portal

2. Create an Account (if you don’t have one):

   • To apply for device registration, you will need to create an account on the MDR portal if you do not already have one.
   • The account should be created by the applicant or the Local Authorized Representative (LAR) if the manufacturer is located outside of Singapore.
   • After registration, you will be able to log in and start your application.

3. Log in to the Portal:

   • After you have registered, log in to the MDR portal with your username and password.

4. Prepare the Required Documentation:

   • Device Information: Description, intended use, technical specifications, and labeling.
   • Clinical Data: If applicable, provide clinical trial results or a Clinical Evaluation Report (CER).
   • Manufacturing Information: Manufacturer details, GMP compliance, and quality management system certifications (such as ISO 13485).
   • Risk Management Documentation: Risk management reports following ISO 14971.
   • Regulatory Documents: Include any international certifications (e.g., CE mark, FDA approval, etc.).

5. Fill Out the Registration Application:

   • Complete the application form on the MDR portal by providing all the necessary information about the device, including its classification as Class C, intended use, and all supporting documents.
   • Ensure that all the documentation is in compliance with HSA guidelines.

6. Pay the Registration Fee:

   • After filling out the application, you will be required to pay the registration fee.
   • For Class C devices, the registration fee typically ranges between SGD 3,000 to SGD 5,000. The exact fee will be confirmed during the submission process.

7. Submit the Application:

   • Once you have filled out the form and uploaded all the required documents, you can submit your application electronically through the MDR portal.

8. HSA Review and Evaluation:

   • After submission, HSA will review the application and evaluate the device based on the provided documentation.
   • The review process for Class C devices typically takes 3 to 6 months, depending on the complexity of the device and the completeness of the submission.

9. Approval and Registration:

   • Once the application is approved, you will receive confirmation, and your device will be officially registered.
   • The registration is valid for 5 years, after which you will need to renew it.

Where to Apply for Class C Medical Device Registration:

You must apply through the HSA Medical Device Registration (MDR) Portal, which is the official platform for medical device registration in Singapore.

• Website: HSA Medical Device Registration Portal

Additional Information:

• Local Authorized Representative (LAR): If the manufacturer is located outside Singapore, a Local Authorized Representative (LAR) in Singapore must submit the application on the manufacturer's behalf.
• Application Status: After submission, you can track the status of your application through the portal.

This process ensures that your Class C medical device complies with Singapore’s regulatory requirements, including safety and performance standards. If you have further questions or need more specific details, feel free to ask!

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