Class C medical devices in Malaysia are categorized as those that pose a moderate to high risk to patients and users. This classification typically includes devices such as surgical instruments, diagnostic imaging devices, and certain implantable devices. Registration of Class C medical devices with the Malaysian Medical Device Authority (MDA) ensures that they meet safety, effectiveness, and quality standards before being marketed in Malaysia.

Overview of Class C Medical Device Registration

1. Definition: Class C devices are those that present a moderate to high risk to patients, requiring stringent regulatory controls.
2. Purpose: The registration process is designed to assess the safety and efficacy of the device, ensuring it complies with Malaysian regulatory standards.

Application Process for Class C Medical Device Registration

1. Determine Device Classification:

   • Confirm that your device qualifies as Class C according to the MDA classification criteria.

2. Prepare Required Documentation:

   • Technical Documentation: This should include details about the device's design, materials, manufacturing processes, and intended use.
   • Clinical Evaluation Report: Evidence supporting the safety and performance of the device based on clinical data.
   • Quality Management System (QMS): Documentation proving compliance with ISO 13485 or other relevant standards.
   • Labeling and Instructions for Use: Ensure that labeling meets regulatory requirements, including product information and user instructions.

3. Local Authorized Representative:

   • If you are an overseas manufacturer, appoint a local representative in Malaysia who will handle regulatory communications and responsibilities.

4. Submit the Application:

   • Complete the Medical Device Registration Application Form (MD-1) and submit it via the MDA's online portal, known as e-MDA.

5. Payment of Registration Fees:

   • Pay the required registration fees, which vary depending on the classification of the device. Check the MDA website for the latest fee structure.

6. MDA Evaluation:

   • The MDA will assess the submitted application and may request additional information or clarification.

7. Issuance of Registration Certificate:

   • Upon successful evaluation and approval, the MDA will issue a Certificate of Registration for your Class C medical device.

8. Post-Market Surveillance:

   • After registration, comply with post-market requirements, including monitoring for adverse events and reporting as necessary.

Resources for Further Information

• MDA Website: Access official guidelines, application forms, and additional information about the registration process here.
• Medical Device Act 737: Familiarize yourself with the legislation governing medical device regulation in Malaysia.

Tips for a Successful Application

• Ensure all documentation is complete and accurate to avoid delays.
• Consider consulting a regulatory expert for guidance, especially if you are unfamiliar with Malaysian regulations.

If you have specific questions or need further clarification on any part of the process, feel free to ask!

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