To apply for Class B medical device registration in Malaysia, you will need to submit your application through the Medical Device Authority (MDA). Here’s how to do it:

Application Portal:

• MeDC@St: The primary platform for submitting medical device registration applications is the MDA's online portal, known as MeDC@St (Medical Device Information and Management System).

Steps to Access and Apply:

1. Create an Account:

   • If you don’t have an account, register on the MeDC@St portal. You'll need to provide some basic information to create your user profile.

2. Login:

   • After creating your account, log in to the portal.

3. Complete the Application Form:

   • Fill out the online application form for Class B medical device registration. Ensure all required fields are completed accurately.

4. Upload Documentation:

   • Attach all necessary documents, including the technical file, quality management system documentation, risk management documentation, and clinical evaluation report.

5. Submit Application:

   • Once everything is complete, submit your application through the portal.

6. Payment of Fees:

   • Pay the registration fees as outlined in the application process.

Contact Information:

• If you have specific questions or need assistance, you can contact the MDA directly through their official website or customer service channels.

Additional Resources:

• MDA Website: For the most accurate and up-to-date information regarding registration processes, guidelines, and requirements, visit the MDA’s official website.

By using the MeDC@St portal and following the outlined steps, you can efficiently apply for Class B medical device registration in Malaysia.