The application process for Class C medical device registration with the Malaysian Medical Device Authority (MDA) involves several well-defined steps. Here’s a comprehensive overview of the application processes:

1. Preliminary Preparation

• Device Classification: Confirm that your device is classified as Class C based on its intended use and risk profile.
• Regulatory Knowledge: Familiarize yourself with the Medical Device Act 737 and the Medical Device Regulations (MDR) 2012 to understand the requirements specific to Class C devices.

2. Establish Quality Management System (QMS)

• Implement ISO 13485: Ensure your organization has a Quality Management System compliant with ISO 13485, covering design, production, and post-market activities.
• Document Control: Prepare and maintain documentation, including standard operating procedures (SOPs), training records, and internal audit reports.

3. Compile Required Documentation

• Technical Documentation: Prepare comprehensive technical files that include:
  • Device description and specifications.
  • Risk management documentation (ISO 14971).
  • Clinical evaluation report (CER) demonstrating safety and efficacy.
  • Performance testing data (safety, biocompatibility, etc.).
• Labeling and IFU: Ensure compliance with MDA requirements for device labeling and Instructions for Use (IFU).

4. Appoint a Local Authorized Representative (if applicable)

• For foreign manufacturers, appoint a registered local authorized representative to handle regulatory submissions and communication with the MDA.

5. Create a MeDC@St Portal Account

• Registration: Register an account on the MeDC@St portal (https://medcast.mda.gov.my), the official platform for submitting medical device applications.

6. Complete the Application Form

• Choose the Correct Form: Fill out the appropriate application form for Class C medical device registration available on the MeDC@St portal.

7. Submit the Application

• Upload Documentation: Attach all required documents to the application form, ensuring completeness and accuracy.
• Payment of Fees: Pay the required registration fees as specified by the MDA. Payment can typically be made online through the MeDC@St portal.

8. Review by MDA

• Initial Review: Upon submission, MDA conducts an initial review to ensure all required documents are included.
• Technical Evaluation: The MDA’s technical team will evaluate the technical documentation to assess compliance with applicable standards and regulations.
• Additional Information Requests: Be prepared to respond to any queries or requests for additional information from MDA during the evaluation process.

9. Decision Notification

• Approval or Rejection: MDA will notify you of the outcome of the application. If approved, a registration certificate will be issued.
• Conditions for Approval: MDA may impose conditions or require additional post-market surveillance activities as part of the approval.

10. Post-Registration Obligations

• Post-Market Surveillance: Implement a post-market surveillance system to monitor the device’s performance once it is on the market.
• Adverse Event Reporting: Report any adverse events or incidents associated with the device to MDA within the required timeframe.

11. Renewal Preparation

• Track Registration Validity: Monitor the registration expiration date and prepare for renewal, typically required every five years.

12. Continuous Improvement

• Data Utilization: Use feedback from post-market surveillance to improve the device and its safety profile.
• Stay Updated: Keep abreast of any changes in regulations and guidelines that may impact your device or registration process.

By following these steps, manufacturers can effectively navigate the application process for Class C medical device registration with the Malaysian MDA. If you need more specific details about any step or have additional questions, feel free to ask!

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