The registration cycle for Class B medical devices in Malaysia generally follows these timeframes:

1. Preparation Phase

• Document Preparation: Preparing the necessary documentation (technical file, clinical data, risk management reports, etc.) can take several weeks to months, depending on the readiness and completeness of the materials.

2. Submission Phase

• MeDC@St Submission: Once the documentation is ready, the actual submission process via the MeDC@St portal is relatively quick, often taking a few days.

3. Review Phase

• Initial Review: The Medical Device Authority (MDA) performs an initial check of the submission to ensure all required documents and information are included. This initial review typically takes 1-2 weeks.
• Detailed Evaluation: The MDA conducts a detailed review of the technical documentation, clinical evidence, and risk management reports. This evaluation generally takes 3 to 6 months, depending on the complexity of the device and the completeness of the submitted information.
• Additional Information Requests: If the MDA requires further clarification or additional information, the review process can be extended. Responding promptly to any requests can help minimize delays.

4. Approval Phase

• Issuance of Certificate: Once the review is complete and if the device meets all regulatory requirements, the MDA will issue a Certificate of Registration. This step typically follows the completion of the detailed evaluation.

Overall Timeframe

• The entire registration cycle for Class B medical devices in Malaysia typically ranges from 3 to 6 months from the time of submission to the receipt of the Certificate of Registration. This includes both the review process and the time needed to address any additional information requests.

Factors Affecting the Timeline

• Completeness and Accuracy of Submission: Incomplete or inaccurate documentation can lead to delays as the MDA may request additional information.
• Complexity of the Device: Devices that are more complex or require extensive clinical data may undergo a more thorough evaluation, potentially extending the review time.
• Response Time: Timely responses to any MDA queries or additional information requests can help keep the process on track.

By ensuring that all documentation is complete and accurate and responding promptly to any additional requests from the MDA, you can help streamline the registration process and adhere to the expected timeline.

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