The process for Class B medical device registration in Malaysia involves several key steps, along with specific required materials and important considerations. Here’s a detailed overview:

Process for Class B Medical Device Registration:

1. Determine Device Classification:

   • Confirm that your device is classified as Class B according to the MDA's guidelines.

2. Prepare Required Materials:

   • Technical File:
     • Device description and intended use.
     • Design specifications and manufacturing processes.
     • Labeling, including instructions for use and safety information.
   • Quality Management System (QMS) Documentation:
     • Evidence of compliance with ISO 13485 or similar standards.
   • Risk Management Documentation:
     • Risk analysis and management plan in line with ISO 14971.
   • Clinical Evaluation Report:
     • Data demonstrating safety and performance, including clinical data if applicable.
   • Manufacturer Information:
     • Details about the manufacturer, including name, address, and contact information.
   • Product Labels and Instructions for Use:
     • Drafts or samples of the labeling that complies with regulatory requirements.

3. Create an Account on MeDC@St:

   • Register on the MDA’s online platform, MeDC@St, where applications are submitted.

4. Complete the Application:

   • Fill out the online application form with accurate information.

5. Upload Required Documents:

   • Attach all necessary documentation to the application.

6. Pay Registration Fees:

   • Pay the applicable fees, which vary based on the device type.

7. Review Process:

   • The MDA will review your application. Be prepared to provide additional information or clarification if requested.

8. Approval and Issuance of Registration Certificate:

   • If approved, you will receive a registration certificate, allowing you to market your device in Malaysia.

9. Post-Market Surveillance:

   • Implement a plan for monitoring the device's performance after market entry, including reporting adverse events.

Important Considerations:

• Consult MDA Guidelines: Regularly check the MDA’s official guidelines for any updates or changes in the registration process or requirements.
• Quality Management System: Ensure that your QMS is well-documented and compliant with relevant standards, as this will be a crucial part of the review process.
• Thorough Documentation: Accurate and complete documentation is essential to avoid delays in the review process.
• Communication: Maintain open lines of communication with the MDA during the review process to address any questions or requests for information promptly.
• Expert Guidance: Consider consulting with regulatory experts or professionals experienced in the Malaysian medical device registration process to help navigate the requirements effectively.

By following these steps and considering the important factors outlined, you can effectively navigate the Class B medical device registration process in Malaysia.

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