The timeline for Class B medical device registration in Malaysia can vary depending on several factors, including the complexity of the device and the completeness of the application. Here’s a general overview of the expected timeline:

1. Preparation of Documentation:

• Timeframe: This can take anywhere from a few weeks to several months, depending on the availability of data and the thoroughness of documentation. This includes gathering the technical file, quality management system documentation, risk management reports, and clinical evaluation data.

2. Online Submission:

• Timeframe: Once the documents are prepared, the actual online submission through the MeDC@St portal can be completed in a day or two.

3. MDA Review Process:

• Timeframe: The MDA typically takes about 60 to 90 days to review a complete application. This period can vary based on:
  • The complexity of the device.
  • The workload of the MDA at the time of submission.
  • Whether additional information or clarification is required from the applicant.

4. Response to Queries:

• If the MDA requests additional information or clarification during the review, the timeline may extend based on how quickly the applicant can respond.

5. Approval and Issuance of Registration Certificate:

• Once the application is approved, the registration certificate is usually issued shortly thereafter, often within a few days.

6. Total Timeline:

• In total, from the beginning of documentation preparation to receiving the registration certificate, the entire process can take anywhere from 3 to 6 months or more, depending on the factors mentioned above.

Important Considerations:

• Plan for Delays: It’s wise to account for potential delays, especially if additional information is requested.
• Consult MDA Guidelines: Regularly check the MDA’s official guidelines for any updates that might affect processing times.
• Expert Assistance: If you’re unfamiliar with the process, consider engaging a regulatory consultant to help streamline your application and minimize delays.

By understanding the timeline and planning accordingly, you can navigate the Class B medical device registration process more effectively.

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