The duration of Class B medical device registration in Malaysia can vary based on several factors, but here’s a general overview of the timeline:

1. Preparation Phase:

• Timeframe: This phase, where you gather and prepare all necessary documentation (technical file, risk management plans, quality management system documents, etc.), can take from a few weeks to several months. The time required depends on the complexity of the device and the completeness of the existing documentation.

2. Submission Phase:

• Once the documentation is ready, you can complete the online application through the MeDC@St portal, which typically takes a day or two.

3. Review Process:

• Timeframe: After submission, the MDA will generally take 60 to 90 days to review the application. This period may vary based on:
  • The completeness and clarity of the submitted documentation.
  • The complexity of the device.
  • The current workload and capacity of the MDA.

4. Response to Queries:

• If the MDA requires additional information or clarification during the review, this may extend the timeline. The response time to MDA queries can affect the overall duration.

5. Approval Phase:

• If the application is approved, the registration certificate is typically issued within a few days.

Summary Timeline:

• Overall Duration: From preparation to approval, the total duration can range from approximately 3 to 6 months, depending on the factors mentioned above.

By planning ahead and ensuring that all documentation is thorough and well-prepared, you can help expedite the registration process for your Class B medical device in Malaysia.

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