To apply for the registration of a Class C medical device in Malaysia, you need to follow specific procedures through the Medical Device Centralized Online Application System (MeDC@St). Here’s a step-by-step guide on how to apply and where to submit your application:

Steps to Apply for Class C Medical Device Registration

1. Appoint an Authorized Representative (if applicable)

   • For Non-Malaysian Manufacturers: Appoint a local Authorized Representative (AR) who is registered with the Medical Device Authority (MDA) in Malaysia. The AR will handle the registration process and act as the point of contact with the MDA.

2. Prepare Required Documents

   • Gather and prepare all necessary documentation, including:
     • Common Submission Dossier Template (CSDT)
     • Conformity Assessment Report
     • Quality Management System Certification (e.g., ISO 13485)
     • Authorized Representative Appointment Letter (if applicable)
     • Labeling and Packaging Information
     • Proof of Payment for registration fees

3. Access the MeDC@St System

   • Website: Go to the MeDC@St system through the MDA’s online portal.

4. Create an Account

   • Sign Up: If you do not already have an account, create one by providing your company details and registering with the system.

5. Complete the Application Form

   • Fill Out Form: Log in to the MeDC@St system and complete the online application form for Class C medical devices. Ensure that all required fields are filled accurately.

6. Upload Documentation

   • Upload Files: Upload the prepared documents, including the CSDT, conformity assessment report, quality management system certification, and other required materials.

7. Pay Registration Fees

   • Fee Payment: Pay the applicable registration fees through the MeDC@St system. The fee amount can vary based on the device and specific circumstances.

8. Submit the Application

   • Final Submission: Once all documents are uploaded and fees are paid, submit the application through the MeDC@St system.

9. Track Application Status

   • Monitor: After submission, monitor the status of your application through the MeDC@St system. You may receive requests for additional information or clarification from the MDA.

10. Respond to Queries

    • Additional Information: If the MDA requests further information or clarification, respond promptly to avoid delays in the approval process.

11. Receive Approval

    • Registration Certificate: Upon successful review, the MDA will issue a registration certificate, allowing you to market your Class C medical device in Malaysia.

Where to Apply

• Medical Device Centralized Online Application System (MeDC@St)
  • Website: MeDC@St System
  • Access: Use this online portal to create an account, complete the application form, upload documents, and pay fees.

Additional Information

• Consult MDA Guidelines: Review the latest MDA guidelines and regulations available on their website to ensure compliance with all requirements.
• Engage with a Regulatory Consultant: Consider consulting with a regulatory expert or consultant to assist with the application process, especially if you are unfamiliar with Malaysian regulations or if your device is complex.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn