Obtaining Class D medical device registration with the Medical Device Authority (MDA) in Malaysia typically takes about 6 to 12 months from the start of the preparation process to the final decision. Here’s a breakdown of the key phases and their approximate timelines:

1. Preparation Stage:

• Duration: 3 to 6 months (can vary).
• This phase involves gathering and preparing all necessary technical documentation, conducting clinical evaluations, and ensuring compliance with quality management standards (ISO 13485). The time required here can vary greatly depending on the complexity of the device and the readiness of the documentation.

2. Initial Review by MDA:

• Duration: 2 to 4 weeks.
• After submission, the MDA conducts an initial review to check for completeness and accuracy of the application and its documents.

3. Technical Evaluation:

• Duration: 3 to 6 months.
• The MDA will perform a detailed evaluation of the application. This includes assessing the risk management file, clinical evaluation data, quality management system compliance, and labeling. This phase can take longer if the application requires additional information or clarification.

4. Decision Notification:

• Duration: 1 to 2 weeks.
• After the technical evaluation is complete, the MDA will notify you of their decision regarding the application.

Summary

In summary, the total time frame for obtaining Class D medical device registration with the MDA in Malaysia generally ranges from 6 to 12 months, depending on factors such as the complexity of the device, the completeness of the application, and the responsiveness to any additional information requests from the MDA. Proper preparation and timely communication can help streamline the process.

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