The time it takes to apply for Class C medical device registration with the Malaysian Medical Device Authority (MDA) can vary based on several factors, including the complexity of the device, the completeness of the application, and the current workload of the MDA. Here’s a general overview of the expected timeline and the stages of the review process:

1. Estimated Timeline

• Application Preparation: The time for preparing the necessary documentation and completing the application can take several weeks to months depending on the complexity of the device and the readiness of your documentation.
• Submission to MDA: Once the application is submitted, the MDA aims to complete the review process within 60 to 90 working days. However, this timeline may be affected by factors such as:
  • The need for additional information or clarifications.
  • The complexity of the device.
  • The MDA’s current review workload.

2. Review Process Stages

The review process by the MDA typically involves several stages:

Stage 1: Application Submission

• Initial Review: After you submit the application via the MeDC@St portal, MDA conducts an initial check to ensure that all required documents are included and the application is complete.

Stage 2: Technical Evaluation

• In-depth Review: MDA’s technical team evaluates the technical documentation, including the device description, risk management, clinical evaluation, and performance data.
• Compliance Assessment: The evaluation focuses on compliance with applicable regulations, standards, and guidelines.
• Possible Additional Information Requests: If the MDA identifies any deficiencies or requires further information, they will issue a request for clarification or additional data.

Stage 3: Consultation (if necessary)

• Expert Consultation: In some cases, MDA may consult external experts or advisory panels, especially for complex devices or novel technologies.

Stage 4: Decision Making

• Approval or Rejection: After completing the technical evaluation and any necessary consultations, MDA will make a decision regarding the application.
• Issuance of Certificate: If approved, the MDA will issue a registration certificate for the Class C medical device.
• Conditions or Post-Market Requirements: The MDA may impose certain conditions or requirements for post-market surveillance.

Stage 5: Notification of Outcome

• Communication: MDA will notify the applicant of the outcome of the review. This notification will include details on any conditions attached to the approval, if applicable.

3. Post-Review Obligations

• Implementation of Post-Market Surveillance: Upon successful registration, manufacturers must implement a post-market surveillance plan to monitor the device's safety and effectiveness in the market.
• Reporting Adverse Events: Any adverse events related to the device must be reported to MDA as required.

While the overall timeline can be estimated, it is crucial to ensure that your application is comprehensive and meets all MDA requirements to avoid delays in the review process. Proactive communication with MDA and addressing any queries promptly can also help expedite the process. If you have more specific questions or need further details, feel free to ask!