The timeline for applying for Class B medical device registration in Malaysia typically involves several phases, with the overall process taking about 3 to 6 months from preparation to approval. Here’s a breakdown of the key timeframes and the review process:

Timeline Breakdown

1. Preparation of Documentation:

   • Timeframe: This phase can take anywhere from a few weeks to several months, depending on the complexity of the device and the completeness of the documentation. It involves gathering all necessary technical documents, risk management plans, quality management system records, and clinical evaluation data.

2. Online Submission:

   • Timeframe: Completing the online application through the MeDC@St portal can usually be done in a day or two once documentation is ready.

3. MDA Review Process:

   • Timeframe: The MDA typically takes 60 to 90 days to review the application once it is submitted. The exact duration can vary based on:
     • The complexity of the device.
     • The completeness and clarity of the submitted documentation.
     • The current workload of the MDA.

4. Response to Queries:

   • If the MDA requires additional information or clarification during the review, this may extend the timeline. The time it takes for the applicant to respond can also affect the overall duration.

5. Approval and Issuance of Registration Certificate:

   • Timeframe: Once the application is approved, you should receive the registration certificate within a few days.

Review Process Overview

The MDA’s review process for Class B medical device registration typically includes the following steps:

1. Initial Assessment:

   • The MDA conducts a preliminary assessment of the application to ensure that all required documentation has been submitted and that the application is complete.

2. Technical Review:

   • The MDA evaluates the technical file, including the device description, design specifications, risk management documentation, and clinical evaluation data. This review assesses the safety, effectiveness, and compliance of the device with relevant standards and regulations.

3. Quality Management System Evaluation:

   • The MDA may assess the manufacturer’s quality management system documentation to ensure compliance with ISO 13485 or similar standards.

4. Risk Assessment:

   • An evaluation of the risk management plan to determine if potential risks associated with the device have been adequately identified and mitigated.

5. Request for Additional Information:

   • If the MDA finds any gaps or needs further clarification, they will issue a request for additional information. The applicant must respond promptly to these requests to avoid delays.

6. Final Decision:

   • After completing the review, the MDA will make a final decision regarding the approval or rejection of the application. If approved, the registration certificate is issued.

Conclusion

In summary, while the entire process from preparation to approval can take a few months, the MDA’s review process specifically spans around 60 to 90 days, depending on various factors. Being well-prepared and submitting comprehensive documentation can help expedite the review and approval timeline.

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