The processing cycle for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia typically follows a structured timeline. Here’s an overview of the stages involved in the processing cycle:

1. Preparation Stage:

• Duration: Varies based on the complexity of the device and the completeness of the documentation.
• Activities: Gather and prepare all required documents, including technical files, clinical evaluation reports, labeling, and quality management system documentation. This stage can take several weeks to months, depending on your readiness.

2. Submission:

• Duration: Immediate upon completion of the application and payment of fees.
• Activities: Submit the completed application through the MDA’s e-Register system and ensure all required materials are uploaded.

3. Initial Review:

• Duration: Approximately 2 to 4 weeks.
• Activities: The MDA conducts an initial review to verify that all required documents are submitted and that the application is complete. If any documents are missing or if there are discrepancies, the MDA may contact you for clarification.

4. Technical Evaluation:

• Duration: Typically 3 to 6 months, but it can vary.
• Activities: The MDA performs a detailed technical evaluation of the application. This includes reviewing the risk management file, clinical evaluation data, and compliance with applicable standards. During this time, the MDA may request additional information or clarification.

5. Decision:

• Duration: 1 to 2 weeks.
• Activities: After the technical evaluation, the MDA will make a decision on your application. If approved, you will receive a registration certificate. If there are issues, you will be notified of the specific reasons for rejection and may be required to address these concerns before resubmitting.

6. Post-Decision:

• Duration: Ongoing.
• Activities: After registration, you must comply with post-market surveillance requirements and report any adverse events related to the device.

Total Estimated Processing Time:

• The overall processing time from submission to approval can range from 6 to 12 months. This timeframe depends on various factors, including the completeness of the application, the complexity of the device, and the efficiency of the MDA's review process.

Conclusion:

It's important to plan for potential delays and to be responsive to any requests from the MDA during the evaluation process. Being well-prepared with all documentation can help streamline the registration cycle for your Class D medical device.

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