In Malaysia, you can apply for Class A medical device registration through the Medical Device Authority (MDA) using their online system, MeDC@St (Medical Device Centralized Online Application System). Here’s how you can proceed:

1. MeDC@St Online Application System

MeDC@St is the primary platform for all medical device-related applications in Malaysia, including Class A device registration.

Steps to Apply:

1. Access MeDC@St System:

   • Visit the MeDC@St website or access it via the Medical Device Authority’s official site.

2. Create an Account:

   • If you do not have an account, you will need to create one. Register as a new user by providing necessary details about your establishment or yourself as the Local Authorized Representative (LAR).

3. Login to the System:

   • Use your credentials to log in to the MeDC@St system.

4. Prepare and Submit the Application:

   • Complete the online application form for Class A medical device registration. Ensure all details are accurate and up-to-date.
   • Upload required documents such as:
     • Technical documentation
     • Declaration of Conformity (DoC)
     • Instructions for Use (IFU)
     • Labeling and packaging details
   • Pay the application fee as specified in the system. The fee can be paid online through the MeDC@St platform.

5. Monitor Application Status:

   • After submission, you can track the status of your application through the MeDC@St system. The MDA may request additional information or clarifications during the review process.

2. Medical Device Authority (MDA) Office

For any issues with the online system or if you need assistance, you can contact the MDA directly.

Contact Information:

• Website: www.mda.gov.my
• Phone: Available on the MDA website for direct inquiries.
• Email: Specific email addresses for different inquiries can be found on the MDA website.
• Address: The physical address of the MDA can also be found on their website if you need to visit or send physical documentation.

3. Preparation and Support

• Consultation: Consider consulting a regulatory expert or consultant if you need assistance with the application process. They can help ensure that your submission is complete and complies with MDA requirements.
• Documentation: Make sure all required documentation is prepared according to MDA guidelines to avoid delays in the application process.

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