The cycle for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia typically involves several phases, with an estimated total duration ranging from 6 to 12 months. Here’s a breakdown of the key phases and their approximate timelines:

1. Preparation Stage:

• Duration: 3 to 6 months (can vary significantly).
• This phase includes gathering and preparing all necessary technical documentation, conducting clinical evaluations, and ensuring compliance with quality management standards (ISO 13485).

2. Initial Review by MDA:

• Duration: 2 to 4 weeks.
• After submission, the MDA will conduct an initial review to ensure that all required documents are included and that the application is complete.

3. Technical Evaluation:

• Duration: 3 to 6 months.
• The MDA performs a detailed evaluation of the application. The length of this phase can vary based on the complexity of the device and the completeness of the information provided. If additional information is needed, it can extend the review period.

4. Decision Notification:

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

Summary

In total, the entire process from preparation to decision notification can take 6 to 12 months. Factors such as the complexity of the device, the completeness of the application, and any requests for additional information from the MDA can influence the timeline. To help ensure a smoother and quicker registration process, it’s crucial to prepare all documentation thoroughly and respond promptly to any requests from the MDA during the evaluation.

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