The costs and timeframes for registering a B-class in vitro diagnostic (IVD) medical device with Malaysia's Medical Device Authority (MDA) vary depending on the device's specifics, document completeness, and complexity of the application. Here’s an overview:

1. Costs

• Registration Fees: The fees for Class B IVD device registration typically range from approximately MYR 2,500 to MYR 5,000 (USD 500 to USD 1,000). The exact cost can vary based on the device type, application specifics, and potential additional assessments. MDA periodically updates its fee schedule, so it’s best to consult their latest fee structure or reach out directly for accurate information.

• Authorized Representative Fees: If the manufacturer is based outside Malaysia, they need a local authorized representative, who may charge an additional fee for their services. Fees vary based on the representative’s services but typically range from MYR 3,000 to MYR 10,000 (USD 600 to USD 2,000) annually, depending on the complexity and scope of services.

• Quality Management System (QMS) Certification Costs: Compliance with ISO 13485, if not already established, requires certification. This can cost USD 5,000 to USD 15,000 depending on the manufacturer’s location, organizational size, and certification body.

• Consultant Fees (optional): Hiring a regulatory consultant to assist with the application can cost between USD 1,000 to USD 10,000 based on the level of support needed.

2. Timeframes

• Preparation Time: The time required to compile the technical documentation and ensure QMS compliance can vary significantly:

  • Existing QMS Certification: If the manufacturer already has an ISO 13485-compliant QMS, documentation preparation can take about 1–2 months.
  • Without QMS Certification: Implementing an ISO 13485 QMS and gathering supporting data may take 6–12 months.

• MDA Review Time: The MDA's processing and review time for Class B devices typically takes between 3 to 6 months, assuming the application is complete and no additional information requests are made. However, if MDA requests clarifications or further data, this can extend the review period by several weeks or months.

• Total Registration Time: From preparation to approval, the entire process can range from 6 to 12 months if the QMS and documentation are already in place. For new market entrants without prior certification, the entire process may extend to 12–18 months.

Additional Factors Influencing Costs and Timeframes

• Complexity of the Device: More complex IVDs or devices with novel technology may require more extensive documentation, higher registration fees, and possibly a longer evaluation period.
• Post-Market Requirements: MDA mandates post-market surveillance and reporting for registered devices, and costs associated with these activities may arise.
• Renewal Fees: Registration certificates are typically valid for 5 years, after which a renewal application with associated fees will be required.

These are estimated costs and timelines, and it’s recommended to consult MDA’s latest guidance or seek assistance from a regulatory consultant for precise figures.