To apply for Class B medical device registration in Malaysia, follow these steps:

Application Steps:

1. Determine Device Classification:

   • Ensure your device is classified as Class B according to the Medical Device Authority (MDA) guidelines.

2. Prepare Required Documentation:

   • Compile the necessary documents, including:
     • Technical File (device description, design specifications, manufacturing process).
     • Quality Management System (QMS) documentation (ISO 13485 compliance).
     • Risk Management documentation (ISO 14971).
     • Clinical Evaluation Report.
     • Product labeling (labels and instructions for use).
     • Manufacturer information.

3. Create an Account on MeDC@St:

   • Register on the MDA's online portal, MeDC@St (Medical Device Information and Management System).

4. Complete the Online Application:

   • Log in to MeDC@St and fill out the application form for Class B medical device registration.

5. Upload Documentation:

   • Attach all prepared documents to the application in the portal.

6. Pay Registration Fees:

   • Pay the applicable fees, which vary based on the device type.

7. Review Process:

   • The MDA will review your application. Be ready to provide additional information if requested.

8. Receive Registration Certificate:

   • If approved, you will receive a registration certificate, allowing you to market your device in Malaysia.

Where to Handle the Application:

• Online Portal: All applications for Class B medical device registration are handled through the MeDC@St portal. There’s no need for physical submission; the entire process is conducted online.

Additional Tips:

• Contact MDA: For any inquiries or assistance, you can reach out to the MDA through their official website or contact channels.
• Consult Guidelines: Review the MDA’s guidelines regularly to stay updated on any changes in requirements or procedures.

By following these steps and utilizing the MeDC@St portal, you can effectively apply for Class B medical device registration in Malaysia.