For the registration of Class C medical devices in Malaysia, you need to prepare a comprehensive set of documents and materials to comply with the Medical Device Authority (MDA) requirements. Here’s a detailed guide on the materials needed and how to prepare the application documents:

Materials Needed for Class C Medical Device Registration

1. Common Submission Dossier Template (CSDT)

   • Device Description: Provide detailed information about the device, including its design, intended use, functionality, and technical specifications.
   • Risk Management: Submit a risk analysis report that identifies potential risks associated with the device, along with risk control measures. This should align with ISO 14971 (Risk Management for Medical Devices).
   • Clinical Evidence: Include clinical data or studies demonstrating the device’s safety and effectiveness. This might involve clinical trials, literature reviews, or real-world evidence.
   • Manufacturing Information: Detail the manufacturing process, quality control measures, and the facilities involved. Include information on the production environment and quality assurance practices.
   • Labeling and Instructions for Use: Provide samples of the device’s labeling, packaging, and instructions for use (IFU). Ensure these are clear, accurate, and comply with regulatory requirements.
   • Compliance with Essential Principles: Demonstrate how the device complies with the essential principles of safety and performance as specified by the MDA.

2. Conformity Assessment Report

   • Obtain a report from a recognized Conformity Assessment Body (CAB) confirming that the device meets applicable safety and performance standards. This could be a Full Quality Assurance (FQA) Audit or Type Examination, depending on the device and its classification.

3. Quality Management System Certification

   • Provide evidence of a valid Quality Management System (QMS) certification, such as ISO 13485. This certification should be current and cover the aspects of manufacturing and quality management relevant to the device.

4. Authorized Representative Appointment Letter (if applicable)

   • If the manufacturer is based outside Malaysia, provide a letter appointing a local Authorized Representative (AR). This letter should detail the AR’s responsibilities and confirm their registration with the MDA.

5. Proof of Payment

   • Submit proof of payment for the registration fees. The payment can typically be made online through the MeDC@St system.

How to Prepare the Application Documents

1. Gather and Compile Documentation

   • Collect all required documents and ensure they are complete and accurate. This involves gathering technical data, clinical evidence, risk management reports, and manufacturing information.

2. Format and Organize the Documents

   • Use the Common Submission Dossier Template (CSDT) format to organize your documents. Ensure that each section is clearly labeled and follows the structure outlined by the MDA.

3. Prepare Clinical Evidence

   • Ensure that clinical data is comprehensive and relevant. This may involve conducting clinical studies or compiling existing clinical literature.

4. Ensure Compliance with Standards

   • Verify that your device complies with relevant standards, such as ISO 13485 for QMS and ISO 14971 for risk management. Provide certification and documentation to support this.

5. Draft and Review Labeling

   • Prepare labeling and instructions for use in compliance with regulatory requirements. Ensure they are clear, user-friendly, and provide all necessary information for safe use.

6. Complete the Application Form

   • Access the MeDC@St system and complete the online application form. Ensure that all fields are filled out accurately and completely.

7. Upload and Submit Documents

   • Upload the prepared documents to the MeDC@St system. Double-check that all required documents are included and properly formatted.

8. Pay Fees

   • Make the necessary registration fee payments through the MeDC@St system and ensure you receive confirmation of payment.

9. Track Application Status

   • Monitor the status of your application through the MeDC@St system. Be prepared to respond to any requests for additional information or clarification from the MDA.

Summary of Documents to Prepare

1. Common Submission Dossier Template (CSDT)
2. Conformity Assessment Report
3. Quality Management System Certification (e.g., ISO 13485)
4. Authorized Representative Appointment Letter (if applicable)
5. Labeling and Instructions for Use
6. Proof of Payment

Resources

• Medical Device Authority (MDA) Website
• MeDC@St System
• Medical Device Act 2012 (Act 737)

By following these guidelines and ensuring that all documents are thoroughly prepared, you can facilitate a smooth registration process for your Class C medical device in Malaysia.

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