The process for Class B medical device registration in Malaysia involves several key steps, which are managed through the Medical Device Authority (MDA) and the MeDC@St online portal. Here’s a detailed breakdown of the steps involved:

Step 1: Determine Device Classification

• Verify Classification: Ensure your device is correctly classified as Class B according to the MDA classification guidelines.

Step 2: Prepare Required Documentation

• Compile Technical Documentation: Prepare the necessary documents, including:
  • Technical file (device description, design specifications, manufacturing process).
  • Quality management system documentation (ISO 13485 compliance).
  • Risk management documentation (ISO 14971).
  • Clinical evaluation report.
  • Product labeling and instructions for use.
  • Manufacturer information and certificates of compliance.

Step 3: Register on MeDC@St

• Create an Account: Register for an account on the MDA’s online submission platform, MeDC@St (Medical Device Information and Management System).

Step 4: Complete the Online Application

• Log In: Access the MeDC@St portal and log in with your credentials.
• Fill Out Application Form: Complete the application form for Class B medical device registration, providing all required information about the device and manufacturer.

Step 5: Upload Documentation

• Attach Required Documents: Upload all prepared documentation as part of your application. Ensure that documents are clear and correctly formatted.

Step 6: Pay Registration Fees

• Submit Payment: Pay the applicable registration fees online through the portal as part of your application submission.

Step 7: MDA Review Process

• Review Period: The MDA will review your application and documentation. This process typically takes 60 to 90 days. Be prepared to respond to any queries or requests for additional information from the MDA.

Step 8: Approval and Issuance of Registration Certificate

• Receive Notification: If the application is approved, you will receive a registration certificate from the MDA.
• Market the Device: Once registered, you can legally market your Class B medical device in Malaysia.

Step 9: Post-Registration Obligations

• Implement Post-Market Surveillance: After registration, maintain a plan for monitoring the device's performance in the market, including reporting adverse events and customer feedback.
• Maintain Compliance: Ensure ongoing compliance with quality management standards and regulatory requirements.

Important Considerations:

• Timeliness: Begin the process well in advance of your target market date to account for preparation and review times.
• Consult Regulatory Experts: If you're unfamiliar with the process, consider engaging regulatory professionals who can assist with application preparation and submission.

By following these steps systematically, you can navigate the Class B medical device registration process in Malaysia effectively.

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