Obtaining Class B medical device registration in Malaysia typically takes around 3 to 6 months from the initial preparation phase to receiving approval. Here’s a breakdown of the timeline:

1. Preparation Phase:

• Duration: This phase can vary significantly based on how quickly you can gather and prepare the necessary documentation, including the technical file, risk management documentation, and quality management system evidence. This could take anywhere from a few weeks to several months, depending on the complexity of the device and the completeness of the existing documentation.

2. Application Submission:

• Duration: Once all documents are ready, completing the online application through the MeDC@St portal can typically be done in a day or two.

3. MDA Review Process:

• Duration: After submission, the MDA generally takes 60 to 90 days to review the application. The exact duration may vary based on factors such as:
  • The clarity and completeness of the submitted documentation.
  • The complexity of the medical device.
  • The current workload of the MDA.

4. Response to Queries:

• If the MDA requires additional information or clarification during the review, the time taken for you to respond can affect the overall timeline.

5. Approval Phase:

• After approval, the registration certificate is usually issued within a few days.

Summary Timeline:

• Overall Duration: From preparation to approval, expect a total duration of approximately 3 to 6 months.

To help expedite the process, ensure thorough preparation of documentation and timely responses to any MDA queries.