The duration of the Class C medical device registration process with the Malaysian Medical Device Authority (MDA) can vary based on several factors, including the complexity of the device, the completeness of the application, and the current workload of the MDA. Here’s a breakdown of the expected timeline:

Estimated Timeline for Class C Medical Device Registration

1. Preparation of Documentation:

   • Duration: This stage can take several weeks to months, depending on how quickly you can compile the necessary technical documentation, clinical evaluation data, risk management information, and quality management system (QMS) documentation.

2. Application Submission:

   • Duration: Once all documentation is prepared, you can submit your application through the MeDC@St portal.

3. Initial Review by MDA:

   • Duration: After submission, MDA conducts an initial review to check for completeness, typically within 5 to 10 working days. If any documents are missing or need clarification, the process may be delayed.

4. Technical Evaluation:

   • Duration: The detailed technical evaluation by the MDA usually takes about 60 to 90 working days. During this phase, the MDA reviews the technical documentation and may request additional information or clarification.

5. Decision Notification:

   • Duration: Once the evaluation is complete, MDA will notify you of the decision regarding your application. The notification is usually sent within a few days after the evaluation concludes.

Total Duration

In total, the entire registration process from preparation to notification can take anywhere from 3 to 6 months or more, depending on various factors such as the complexity of the device and the efficiency of responses to any requests for additional information from the MDA.

Factors Affecting Duration

• Completeness of Application: Ensuring that all required documents are accurate and complete at the time of submission can significantly reduce delays.
• Device Complexity: More complex devices or those requiring extensive clinical data may take longer to evaluate.
• MDA Workload: The MDA’s current workload can affect review times; during busy periods, processing may take longer.

Conclusion

While the initial estimate for Class C medical device registration with the MDA is around 3 to 6 months, being well-prepared with complete and accurate documentation can help streamline the process. If you have specific concerns or need assistance with particular aspects of the registration process, feel free to ask!

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