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Where to apply for Class A medical device MDA registration in Malaysia?
Release time：2024-11-18 16:16:25 The author: source:
To apply for Class A medical device registration in Malaysia, you need to submit your application through the Medical Device Authority (MDA), specifically using the Medical Device Centralized Online Application System (MeDC@St). This is Malaysia's official online portal for medical device registration.

To apply for Class A medical device registration in Malaysia, you need to submit your application through the Medical Device Authority (MDA), specifically using the Medical Device Centralized Online Application System (MeDC@St). This is Malaysia's official online portal for medical device registration.

Steps for Applying through MeDC@St:

  1. Create an Account:

    • Register an account on the MeDC@St portal: https://medcast.mda.gov.my.
    • Both local and foreign manufacturers can create accounts, but foreign manufacturers must appoint a licensed Authorized Representative (AR) in Malaysia to submit the application on their behalf.

  2. Complete the Application:

    • Upload all necessary documentation, including the ISO 13485 certification, technical file, and Declaration of Conformity.
    • Fill in the device information, and provide labeling and intended use details as required by the MDA.

  3. Pay the Registration Fee:

    • Submit the required fee online through the portal.

  4. Await MDA Review and Approval:

    • After submission, the MDA will review the application. Once approved, you will receive a registration certificate through the MeDC@St system.

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