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Where to apply for the registration of Class C medical devices in Malaysia?
Release time：2024-09-14 11:14:24 The author: source:
Website: Go to the MeDC@St system through the MDA’s online portal.

To apply for the registration of Class C medical devices in Malaysia, you need to use the Medical Device Centralized Online Application System, known as MeDC@St. Here’s how you can go about it:

Steps to Apply for Registration:

  1. Access the MeDC@St System

  2. Create an Account

    • If you do not already have an account, you will need to create one. This involves registering with the system and providing necessary details about your company and the device.

  3. Prepare Required Documents

    • Ensure that you have all the necessary documentation ready, including:
      • Common Submission Dossier Template (CSDT)
      • Conformity Assessment Report
      • Manufacturer’s Declaration of Conformity
      • Quality Management System Certification (e.g., ISO 13485)
      • Authorized Representative Appointment Letter (if applicable)
      • Labeling and Packaging Information
      • Proof of Payment for registration fees

  4. Submit the Application

    • Log in to the MeDC@St system and complete the application form. Upload all required documents and information.

  5. Pay the Registration Fees

    • The system will prompt you to pay the registration fees. Payment can typically be made online through the system.

  6. Track the Application

    • After submission, you can track the status of your application through the MeDC@St system. You may receive notifications or requests for additional information from the MDA.

Additional Information:

  • Authorized Representative: If you are a foreign manufacturer, ensure that your Authorized Representative in Malaysia is registered with the MDA and is prepared to handle the application process on your behalf.

  • Consult MDA Guidelines: For detailed guidelines and requirements, refer to the MDA’s official documents and guidelines available on their website.

  • Contact Information: For specific queries or assistance, you can contact the MDA directly via their contact details provided on their website.

Resources:

By following these steps and utilizing the MeDC@St system, you can successfully apply for the registration of Class C medical devices in Malaysia.

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