The processing time for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA) can vary based on several factors, including the completeness of the application, the complexity of the device, and MDA's current workload. Here's a breakdown of the expected timeframes:

1. Preparation Time

• Document Compilation: The time required to prepare and compile the necessary technical documentation and quality management system (QMS) compliance can vary:
  • Existing QMS: If the manufacturer already has an ISO 13485-certified QMS and all required documentation is readily available, preparation may take about 1 to 2 months.
  • New QMS Implementation: For manufacturers needing to establish or certify a QMS, this process can take 6 to 12 months.

2. MDA Review Time

• Once the application is submitted via the Medical Device Information and Safety System (MeDISS), MDA typically takes:
  • 3 to 6 months for the review and evaluation of a complete application for Class B devices. This timeframe can vary based on MDA's current workload and the specific details of the application.

3. Total Timeframe

• Overall Timeline: From preparation to final approval, the entire process may take approximately 6 to 12 months if the QMS and documentation are already in place. However, for new market entrants without prior certifications, the timeframe can extend to 12 to 18 months.

4. Factors Influencing Processing Time

• Completeness of Application: Submitting a comprehensive and well-prepared application can help reduce the review time.
• Request for Additional Information: If MDA requests further information or clarification during the review, this can extend the processing time by several weeks or months.
• Device Complexity: More complex devices may require longer evaluation periods due to the need for additional assessments or testing data.

Summary of Processing Time

• Preparation: 1–12 months, depending on QMS status.
• MDA Review: 3–6 months after application submission.
• Total Time: Approximately 6–18 months from start to finish, based on various factors.

To ensure a smoother and quicker registration process, it is advisable to thoroughly prepare all documentation and maintain open communication with MDA during the application process.

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