The duration for applying 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 the current workload of the MDA. Here's a breakdown of the typical timelines and an overview of the review process:

Timeframe for Application

• Preparation Phase: The preparation of required documents and technical files can take several weeks to months, depending on the complexity of the device and the availability of data.
• Submission to Approval: Once the application is submitted, the review process typically takes about 30 to 90 days. This timeline may vary depending on the following factors:
  • Completeness of the application.
  • Any additional information or clarification requested by MDA.
  • The need for inspections, which may extend the timeframe.

Review Process Overview

The review process by MDA involves several key steps:

1. Initial Review:

   • Completeness Check: MDA conducts an initial review to ensure that the application form is complete and that all required documents have been submitted. Any missing information can delay the process.

2. Technical Evaluation:

   • Safety and Performance Assessment: MDA evaluates the safety, effectiveness, and compliance of the IVD device with Malaysian regulations. This includes a review of:
     • Technical documentation (e.g., performance data, risk management).
     • Clinical evaluation data (if applicable).
     • Labeling and instructions for use.
   • Risk Management Evaluation: The risk management plan is assessed to ensure that risks associated with the device have been identified and appropriately mitigated.

3. Request for Additional Information:

   • If MDA identifies gaps or has questions during the evaluation, they may request additional information from the applicant. The response time to such requests can influence the overall timeline.

4. Manufacturing Site Inspection (if applicable):

   • For certain devices, MDA may require an inspection of the manufacturing facility to verify compliance with quality standards (e.g., ISO 13485). The scheduling and completion of inspections can add to the duration of the review process.

5. Final Review and Decision:

   • After all evaluations are completed, MDA makes a final decision regarding the application. If approved, a registration certificate is issued.

6. Notification of Outcome:

   • The applicant is notified of the decision. If the application is rejected, MDA typically provides reasons for the rejection and may allow for re-submission after addressing the issues identified.

Summary of Timeframe and Review Process

• Preparation Phase: Several weeks to months for document preparation.
• Submission to Approval: Typically 30 to 90 days for the review process.
• Review Process Steps:
  1. Initial completeness check.
  2. Technical evaluation of safety, performance, and compliance.
  3. Request for additional information (if needed).
  4. Manufacturing site inspection (if applicable).
  5. Final review and decision.
  6. Notification of outcome to the applicant.

By understanding the timeframe and the review process, manufacturers can better plan their registration activities and ensure compliance with MDA requirements for B-class IVD medical devices.

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