To apply for Class C medical device registration with the Malaysian Medical Device Authority (MDA), you need to complete the application process through the MeDC@St online platform, which is MDA’s centralized application portal for medical devices. Here’s a step-by-step guide on how and where to apply:

1. Where to Apply

• MeDC@St Portal: All applications for medical device registration with MDA are submitted through the MeDC@St (Medical Device Centralized Online Application System). This platform allows for submission, tracking, and management of medical device registration applications.
• Portal Link: MeDC@St Portal

2. Steps to Apply for Class C Medical Device Registration

Step 1: Register on the MeDC@St Portal

• Access the MeDC@St portal and create an account if you haven’t already. Manufacturers or their local authorized representatives (for foreign manufacturers) need to register with their details.
• For foreign manufacturers, a local authorized representative must handle the account setup and submissions on behalf of the manufacturer.

Step 2: Prepare Required Documentation

• Assemble all necessary documents, including:
  • Technical File: Device description, design and manufacturing information, risk management, and validation reports.
  • Clinical Evaluation Report (CER): Evidence demonstrating the safety and effectiveness of the device.
  • Quality Management System (QMS) Documentation: ISO 13485 certification and other quality assurance documents.
  • Labeling and Instructions for Use (IFU).
  • Declaration of Conformity (DoC).
  • Application Form (MD-1).

Step 3: Complete the Application Form (MD-1)

• Log into the MeDC@St portal, select the registration category (Class C), and complete the MD-1 Application Form.
• Upload all required documents according to the MDA’s guidelines. Ensure files are formatted as required (usually PDF) and organized for easy access.

Step 4: Pay Application Fees

• Pay the registration fees directly through the MeDC@St portal. Fees for Class C devices range from RM 1,500 to RM 2,000 (approximately $320 to $430 USD). The exact fee will be displayed in the application form section.

Step 5: Submit the Application

• Review all entries and document uploads for accuracy. Once you’re ready, submit the completed application.
• You can track the progress and status of your application directly through the MeDC@St portal.

Step 6: Respond to MDA Queries

• During the review process, MDA may request additional information or clarification. Ensure that you respond promptly to avoid delays.

Step 7: Approval and Certificate Issuance

• Once approved, the MDA will issue a Certificate of Registration, allowing the device to be marketed in Malaysia.

Additional Information

• Post-Market Surveillance: After approval, set up post-market surveillance as required by MDA, including monitoring for adverse events and regular reporting.
• Documentation Updates: The MDA guidelines and fee structures are subject to change, so always refer to the latest information available on the MDA or MeDC@St websites.

Following these steps ensures compliance with MDA requirements for Class C devices and streamlines the application process. Let me know if you need more information on any step or document!

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