Class C medical device registration with the Malaysian Medical Device Authority (MDA) involves a structured process to ensure that the device meets quality, safety, and efficacy standards. Below is a comprehensive guide covering the processes, required materials, and precautions for a successful application.

1. Processes for Class C Medical Device Registration

Step 1: Confirm Device Classification

• Use the MDA’s classification guidelines to ensure that your device qualifies as Class C, which typically includes moderate to high-risk devices like diagnostic imaging equipment, surgical tools, and some implantable devices.

Step 2: Prepare Required Documentation

• Assemble the necessary technical documentation, quality management certification, clinical evidence, and labeling details (see below for a list of required materials).

Step 3: Appoint a Local Authorized Representative (for Foreign Manufacturers)

• If you are an overseas manufacturer, a local authorized representative must be appointed to handle regulatory matters in Malaysia.

Step 4: Complete and Submit the Application via MeDC@St

• Register and log in to the MeDC@St portal on the MDA website (https://medcast.mda.gov.my).
• Complete the Medical Device Registration Application Form (MD-1) and upload all required documentation.

Step 5: Pay Registration Fees

• Make the applicable payment as per the latest fee structure for Class C devices. Fees are displayed on the MDA website and in the application portal.

Step 6: MDA Review and Evaluation

• The MDA will review the application and may request additional information. The review process typically takes 6 to 12 months.

Step 7: Approval and Certificate Issuance

• Upon successful review, MDA will issue a Certificate of Registration, allowing you to market the device in Malaysia.

Step 8: Post-Market Surveillance

• Establish a plan for post-market surveillance to monitor device performance and report adverse events as required by MDA.

2. Required Materials for Registration

The following materials are required for Class C medical device registration:

Technical Documentation

• Device Description and Intended Use: Detailed description, including how the device functions and its intended use.
• Design and Manufacturing Information: Specifications on design, production processes, and materials used.
• Risk Management File: Documentation based on ISO 14971, identifying potential risks and corresponding mitigations.
• Product Verification and Validation: Results from performance testing, biocompatibility, sterility, and stability tests as applicable.

Clinical Evidence

• Clinical Evaluation Report (CER): Evidence supporting device safety and performance, often based on clinical studies, literature, and real-world data.
• Summary of Safety and Performance: Concise document outlining the device’s safety, clinical benefits, and intended outcomes.

Quality Management System (QMS) Documentation

• ISO 13485 Certification or equivalent: Documentation proving that the manufacturing process complies with quality management standards.
• Quality Manual: A document describing the quality management practices and procedures in place.

Labeling and Instructions for Use (IFU)

• Include the device name, intended use, manufacturer’s details, and any warnings or precautions.
• Ensure instructions for use are complete, easy to understand, and compliant with Malaysian requirements.

Declaration of Conformity

• A signed Declaration of Conformity (DoC) from an authorized person, affirming that the device complies with all applicable regulatory requirements.

3. Precautions to Ensure Successful Application

Ensure Completeness and Accuracy

• Incomplete applications or missing documents can lead to delays or rejection. Double-check that all required information is accurate and complete.

Timely Response to MDA Requests

• If the MDA requests additional information or clarification, respond promptly to avoid delays in the review process.

Appoint a Competent Local Representative

• For foreign manufacturers, a reliable local representative can help manage regulatory requirements, communicate effectively with MDA, and handle any compliance issues that arise post-market.

Keep Documentation Organized

• Organize technical files, clinical data, and QMS documents to simplify review for MDA evaluators. Clear organization and logical formatting reduce processing time.

Plan for Post-Market Surveillance Early

• Prepare a post-market surveillance plan, including protocols for adverse event monitoring and incident reporting, as MDA requires these for continued compliance.

Stay Updated on MDA Requirements

• MDA guidelines and regulations may change. Regularly review the MDA website and official publications to stay compliant with the latest regulatory requirements.

Additional Resources

• MDA Website: https://www.mda.gov.my for guidelines, application forms, and fee structure.
• MeDC@St Portal: The primary platform for submission and application tracking.

By following these processes, preparing the necessary materials, and taking the recommended precautions, you can increase the likelihood of a smooth and successful registration with the MDA for your Class C medical device. Let me know if you need assistance with any particular aspect!

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