The process for registering a Class C medical device with the Malaysian Medical Device Authority (MDA) involves several key steps, from preparing the necessary documentation to submitting the application through the designated portal. Here’s a detailed overview of the process:

1. Preliminary Preparation

• Understand Classification: Confirm that your device is correctly classified as Class C according to MDA's classification criteria based on the level of risk associated with its use.
• Familiarize with Regulations: Review 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 QMS: Ensure that your organization has an ISO 13485-compliant QMS in place to demonstrate effective management of design, production, and post-market activities.
• Document Procedures: Prepare and document necessary SOPs, training records, and internal audit reports.

3. Compile Technical Documentation

• Device Description: Create comprehensive documentation describing the device, its intended use, and specifications.
• Risk Management: Develop a risk management file in accordance with ISO 14971, including risk assessment and mitigation strategies.
• Clinical Evaluation Report (CER): Prepare a CER to demonstrate the device’s safety and efficacy based on clinical data.
• Performance Testing: Gather data from relevant performance and safety testing, including biocompatibility and electrical safety.

4. Prepare Labeling and Instructions for Use (IFU)

• Device Labeling: Ensure that the device label complies with MDA requirements, including all necessary information such as the manufacturer's name, device name, and warnings.
• IFU Preparation: Develop clear and comprehensive IFUs that provide instructions on the safe and effective use of the device.

5. Appoint a Local Authorized Representative

• If you are a foreign manufacturer, appoint a local authorized representative registered with MDA who will manage the regulatory submission and communication with MDA.

6. Create a User Account on MeDC@St Portal

• Registration on Portal: Register an account on the MeDC@St portal (https://medcast.mda.gov.my), the official online platform for submitting medical device applications to MDA.
• Familiarization: Familiarize yourself with the portal's functionality for application submission.

7. Submit the Application

• Complete Application Form: Fill out the appropriate application form for Class C medical device registration available on the MeDC@St portal.
• Upload Required Documents: Attach all necessary documentation, including technical files, labeling, and quality management records.
• Payment of Fees: Pay the required registration fees as outlined by MDA. Payment can typically be done online through the portal.

8. MDA Evaluation Process

• Review by MDA: After submission, the MDA will conduct a review of the application and the accompanying documents to assess compliance with regulatory standards.
• Additional Queries: Be prepared to respond to any queries or requests for further information from MDA during the evaluation process.

9. Notification of Decision

• Approval or Rejection: Once the evaluation is complete, MDA will notify you of the decision. If approved, you will receive a registration certificate.
• Conditions for Approval: In some cases, 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 PMS system to monitor the device’s safety and effectiveness once it is on the market.
• Adverse Event Reporting: Report any adverse events associated with the device to MDA within the specified timeframe.
• Renewal Preparation: Plan for the renewal of registration as required, typically every five years, ensuring ongoing compliance with all regulations.

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

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