Obtaining Class C medical device registration with the Malaysian Medical Device Authority (MDA) typically involves a multi-step process that can take several months. Here's a breakdown of the estimated timeline:

Estimated Timeline for Class C Medical Device Registration

1. Preparation of Documentation:

   • Duration: This stage can take anywhere from a few weeks to several months, depending on the complexity of the device and the readiness of the required documentation (technical files, clinical evaluation data, risk management, etc.).

2. Application Submission:

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

3. Initial Review by MDA:

   • Duration: MDA usually conducts an initial review to check for completeness within 5 to 10 working days. If documents are missing or incomplete, this may extend the timeline.

4. Technical Evaluation:

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

5. Decision Notification:

   • Duration: After completing the technical evaluation, MDA will notify you of the decision, usually within a few days.

Total Estimated Duration

Overall, the entire process from the preparation of documentation to receiving the registration decision can take approximately 3 to 6 months or more, depending on various factors such as:

• Completeness of the application
• Complexity of the medical device
• Current MDA workload

Conclusion

While the total time frame for obtaining Class C medical device registration with the MDA is around 3 to 6 months, preparation time can vary significantly based on the manufacturer’s readiness. Ensuring that all documents are complete and accurate at the time of submission can help streamline the process. If you have any specific concerns or need more detailed information, feel free to ask!

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