To apply for Class A medical device registration in Malaysia, you need to follow a structured process and submit your application through the Medical Device Authority (MDA) using their designated online system. Here’s a step-by-step guide on how to apply and where to submit your application:

Steps to Apply for Class A Medical Device Registration

1. Obtain an Establishment License

Before you can register a medical device, you need an Establishment License if you are the manufacturer, distributor, or Local Authorized Representative (LAR) for the device.

Steps to Obtain an Establishment License:

• Register through the MeDC@St system.
• Submit the required documents, including proof of business registration and ISO 13485 certification (if applicable).
• Pay the license fee.

Timeline: Typically 4 to 6 weeks.

2. Prepare Required Documents for Device Registration

Ensure you have all necessary documents ready, including:

• Device Description: Detailed information about the device, including design, intended use, and functionality.
• Design and Manufacturing Information: Documentation on the design and production processes.
• Risk Management Report: Risk assessment and management plan (ISO 14971).
• Labeling and Packaging Information: Product labels and packaging details.
• Sterilization Process Information (if applicable).
• Clinical Evaluation Data (if applicable).
• Declaration of Conformity (DoC): Statement of compliance with relevant standards.
• Instructions for Use (IFU): Clear usage instructions.

3. Submit the Application through MeDC@St

MeDC@St (Medical Device Centralized Online Application System) is the official online portal for submitting medical device registration applications.

Steps to Submit the Application:

1. Access the MeDC@St System:

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

2. Create or Log in to Your Account:

   • If you do not already have an account, you will need to create one.
   • If you have an account, log in using your credentials.

3. Complete the Online Application Form:

   • Select the appropriate application type for Class A medical devices.
   • Fill out the required fields with accurate information about your device and establishment.

4. Upload Required Documents:

   • Attach all the necessary documents such as technical documentation, DoC, labeling, and IFU.

5. Pay the Registration Fee:

   • Make the payment for the registration fee using the online payment options provided in MeDC@St.
   • Upload proof of payment if required.

6. Submit the Application:

   • Review all the information and documents before submitting.
   • Submit your application through the MeDC@St system.

4. Monitor Application Status

After submission, you can track the status of your application through the MeDC@St system.

• Check regularly for updates or any requests for additional information from the MDA.
• Respond promptly to any requests to avoid delays.

Where to Submit the Application

Application Submission Portal:

• MeDC@St System: All Class A medical device registration applications must be submitted through the MeDC@St online platform.

Contact Information for Assistance:

• Medical Device Authority (MDA) Website: www.mda.gov.my
• Phone and Email: For specific queries or issues with the application process, contact details are available on the MDA website.

Additional Considerations

• Documentation: Ensure that all documentation is complete, accurate, and compliant with MDA guidelines.
• Consultation: Engaging a regulatory consultant can help streamline the process and ensure compliance with all requirements.
• Fees: Be aware of and budget for the registration and establishment license fees.