To apply for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), certain conditions and requirements must be met. Here’s a detailed overview of these conditions:

1. Device Classification

• Classification Confirmation: Ensure that the device is classified as Class B according to MDA's classification guidelines. Class B IVDs are generally considered low to moderate risk devices. The classification is based on factors such as intended use, risk level, and how the device interacts with the body.

2. Quality Management System (QMS) Compliance

• ISO 13485 Certification: Manufacturers must have a QMS that complies with ISO 13485, which outlines requirements for a comprehensive quality management system for the design and manufacture of medical devices. This certification must be current and valid, demonstrating that the manufacturer adheres to international standards for quality and safety.

3. Technical Documentation

• Prepare comprehensive technical documentation that demonstrates the safety, quality, and effectiveness of the device. This includes:
  • Device Description: Detailed information about the device, including its intended use, design, and operating principles.
  • Risk Management Documentation: A risk assessment report in compliance with ISO 14971, outlining potential risks associated with the device and the measures taken to mitigate them.
  • Performance Evaluation Data: Evidence from clinical and non-clinical testing that confirms the device’s efficacy, accuracy, and reliability.
  • Labeling and Instructions for Use (IFU): Clear and comprehensive labeling, including intended use, precautions, and instructions for use, adhering to MDA’s requirements.

4. Manufacturer and Authorized Representative

• Manufacturer Information: The manufacturer must be able to provide clear details about their organization, including the address, contact information, and manufacturing processes.
• Local Authorized Representative: For foreign manufacturers, appointing a local authorized representative in Malaysia is mandatory. This representative acts as the primary point of contact with MDA and is responsible for regulatory compliance and communication.

5. Payment of Fees

• Payment of the required registration fees must be made as part of the application process. The fees vary based on the device and registration type.

6. Adherence to Malaysian Standards

• Compliance with any relevant Malaysian Standards (MS) that may apply to the device type is crucial. These standards ensure that the device meets local safety and performance requirements.

7. Post-Market Obligations

• Manufacturers must be prepared to meet post-market surveillance requirements, including monitoring device performance and safety after it is placed on the market, as well as reporting any adverse events.

Summary of Conditions to Apply

• Confirm that the device is a Class B IVD.
• Ensure compliance with ISO 13485 and provide the necessary certification.
• Prepare all required technical documentation.
• Appoint a local authorized representative if the manufacturer is foreign.
• Pay the required registration fees.
• Ensure adherence to relevant Malaysian Standards.
• Be ready for post-market obligations.

Meeting these conditions is essential for a successful application for B-class IVD registration with MDA.

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