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Where to apply for Class C medical device registration with the Malaysian MDA?
Release time：2024-11-01 13:38:49 The author: source:
To apply for Class C medical device registration in Malaysia, you must use the Medical Device Authority’s (MDA) online system, known as MeDC@St (Medical Device Centralized Online Application System). This platform is specifically designed for the submission, tracking, and management of medical device registration applications.

To apply for Class C medical device registration in Malaysia, you must use the Medical Device Authority’s (MDA) online system, known as MeDC@St (Medical Device Centralized Online Application System). This platform is specifically designed for the submission, tracking, and management of medical device registration applications.

Steps for Applying via MeDC@St

  1. Register an Account:

    • Access the MeDC@St portal on the MDA website (https://medcast.mda.gov.my).
    • Create an account if you do not already have one. For foreign manufacturers, your local authorized representative should manage the account and submit applications on your behalf.

  2. Complete the Application:

    • Log in to your MeDC@St account and fill out the Medical Device Registration Application Form (MD-1).
    • Upload all required documentation, including the technical file, clinical evidence, quality management system documentation, and labeling details.

  3. Pay Application Fees:

    • Make the necessary payment online through the portal. The fee structure for Class C medical devices is listed on the MDA website, but the exact fees will also be displayed during the application process.

  4. Submit and Track the Application:

    • Once your application is complete and all documentation is uploaded, submit it for review. You can monitor the status of your application through the MeDC@St portal.

  5. Respond to Additional Requests:

    • MDA may request further information or clarification during the evaluation process. Ensure prompt responses to avoid delays.

Additional Information

  • MDA Contact Details: If you encounter issues with the MeDC@St portal or have specific questions, you can contact the MDA directly via their official website (https://www.mda.gov.my) for support.

The MeDC@St portal is the primary method for submitting applications to the MDA, providing a centralized and efficient system for managing medical device registrations. Let me know if you need further assistance with any part of this process!

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