To apply for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), applications are submitted through the MDA’s online portal called the Medical Device Information and Safety System (MeDISS).

Steps to Access and Apply via MeDISS

1. Create a MeDISS Account:

   • Go to the MeDISS website.
   • Register for an account if you do not already have one. This account is necessary to initiate and track the registration process.
   • If you are a foreign manufacturer, your appointed local authorized representative will need to complete this process.

2. Log in to MeDISS:

   • Once your account is verified, log in to MeDISS using your credentials.

3. Submit the Application:

   • Select the option for Class B IVD Medical Device Registration.
   • Complete the application form with all necessary details and upload required technical documentation, including product description, risk assessment, performance data, and any supporting QMS documentation.

4. Payment of Fees:

   • After completing the application, you’ll be prompted to pay the registration fee. Payments are typically made online through the MeDISS platform.

5. Track and Respond to Updates:

   • Use MeDISS to monitor the application status and respond to any additional information requests from MDA.

Contact MDA for Assistance

If you encounter any issues, you can contact MDA directly:

• Website: https://www.mda.gov.my
• Phone: +603-8230 0300
• Email: mdb@mda.gov.my

The MeDISS portal is the only official platform for device registration with MDA, ensuring a streamlined and secure submission process.

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