The processing time for Class C medical device registration in Malaysia can vary depending on several factors, including the complexity of the device, the completeness of the submission, and the efficiency of the Medical Device Authority (MDA) review process. Here’s a general overview of the expected timeframe:

Estimated Processing Time

1. Preparation and Submission

   • Document Preparation: Gathering and preparing all required documents, such as the Common Submission Dossier Template (CSDT), conformity assessment reports, and quality management system certifications, can take several weeks to months depending on the complexity of the device and the readiness of the documentation.

2. Conformity Assessment

   • Assessment Duration: The time required for conformity assessment by a recognized Conformity Assessment Body (CAB) can vary. Typically, this can take 2 to 6 months. This includes the Full Quality Assurance (FQA) audit or Type Examination, depending on the device.

3. MDA Review Process

   • Initial Review: Once the application is submitted through the MeDC@St system, the MDA’s initial review can take 3 to 6 months. During this time, the MDA will assess the documentation and may request additional information or clarifications.
   • Additional Information: If the MDA requests further details or clarification, the time required for this can extend the overall processing time. Prompt and complete responses to queries can help avoid delays.

4. Overall Timeframe

   • Total Processing Time: Considering the preparation of documents, conformity assessment, and MDA review, the overall processing time for Class C medical device registration in Malaysia typically ranges from 6 to 12 months. This timeframe can vary based on the specifics of each application and the efficiency of the submission and review processes.

Factors Affecting Processing Time

• Completeness of Submission: Incomplete or inaccurate submissions can lead to delays. Ensure that all documents are accurate, complete, and comply with MDA requirements.
• Complexity of the Device: Devices with more complex features or higher risks may require more thorough review and assessment, potentially extending processing times.
• Conformity Assessment Delays: The time taken by the CAB to complete the conformity assessment can affect the overall processing time.
• MDA Workload: The MDA’s workload and the number of applications being processed can also impact the processing time.

Recommendations

• Prepare Thoroughly: Ensure all documentation is complete and accurate before submission to avoid delays.
• Engage a Consultant: Consider working with a regulatory consultant familiar with MDA processes to streamline the application.
• Monitor Application Status: Regularly check the status of your application through the MeDC@St system and respond promptly to any requests for additional information.

By understanding these timelines and factors, you can better manage expectations and plan for the registration process of your Class C medical device in Malaysia.

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