The costs and time involved in applying for Class C medical device registration with the Malaysian Medical Device Authority (MDA) vary depending on factors such as the complexity of the device, completeness of the documentation, and MDA’s evaluation process. Here’s a general overview of the costs and timelines:

1. Costs for Class C Medical Device Registration

Application Fees

• The MDA charges application fees based on the device classification. For Class C devices, expect fees ranging from RM 1,500 to RM 2,000 (approximately $320 to $430 USD) for initial registration. Check the MDA website or contact them directly for the most current fee schedule, as fees are periodically updated.

Additional Fees (If Applicable)

• Amendment Fees: If the application requires changes after submission, amendment fees may apply, typically ranging from RM 300 to RM 500 (about $65 to $110 USD).
• Renewal Fees: Registration is valid for a period specified by MDA (usually 5 years), after which a renewal application must be filed. Renewal fees for Class C devices are usually similar to the initial application fees.
• Local Authorized Representative Fees: For foreign manufacturers, the local representative may charge service fees for regulatory support. These costs vary by service provider.

2. Time Involved in the Registration Process

Document Preparation Time

• Preparing the necessary technical documentation, clinical evidence, quality management documentation, and labeling may take 2 to 4 months depending on the device’s complexity and the manufacturer’s readiness.

Application Submission and Review Time

• Application Submission: Submitting the application through the MDA’s e-MDA system is typically straightforward if all documentation is ready.
• MDA Evaluation and Approval: MDA usually takes 6 to 12 months to complete the review process for Class C devices. The timeline can vary based on:
  • The complexity of the device and the associated clinical data.
  • The completeness and quality of the submitted documentation.
  • The need for any additional information or clarification during the evaluation process.

Post-Approval Steps

• Post-Market Surveillance Setup: After approval, you must establish post-market surveillance protocols, including adverse event monitoring and reporting. This should be maintained throughout the device's market lifecycle.

Total Time Estimate

• From document preparation to obtaining approval, the entire process can take 8 to 16 months depending on the preparation time and MDA’s evaluation duration.

Additional Tips for Reducing Costs and Time

• Ensure Documentation Completeness: Submitting complete and accurate documentation reduces the chances of delays and additional fees for amendments.
• Consult a Regulatory Expert: If you’re unfamiliar with MDA requirements, consulting a regulatory specialist can streamline the process, potentially saving time and reducing amendment fees.
• Check for Fee Updates: As fees may change, confirm the current fee schedule on the MDA website or directly with the MDA before applying.

This overview provides a general sense of the costs and timelines for Class C medical device registration with the Malaysian MDA. Let me know if you need specific details on any part of the process!