Registering a B-class in vitro diagnostic (IVD) medical device with Malaysia's Medical Device Authority (MDA) requires compliance with several essential documentation, quality, and regulatory standards. Here’s an overview of the requirements:

1. Device Classification Verification

• Confirm that the IVD device is classified as Class B, which generally indicates a low to moderate risk. The classification depends on the intended use, risk level, and degree of invasiveness of the device. If you’re uncertain, MDA guidelines or a regulatory expert can provide guidance.

2. Quality Management System (QMS) Compliance

• ISO 13485 Certification: Manufacturers need to demonstrate compliance with ISO 13485, the internationally recognized standard for medical device quality management systems. This certification assures that the manufacturing process meets global standards for safety, quality, and regulatory compliance.

3. Technical Documentation Requirements

• A technical file with comprehensive information is necessary to support the safety, quality, and performance of the device. The required documents typically include:
  • Device Description: Detailed information on the device, including intended use, design, components, specifications, and operating principles.
  • Risk Management Report: A documented risk assessment following ISO 14971 standards, demonstrating that all potential risks have been identified and mitigated.
  • Performance Evaluation and Testing Data: Evidence demonstrating the device’s effectiveness, accuracy, and reliability, including clinical and non-clinical test results.
  • Labeling and Instructions for Use (IFU): Clear labeling, including the intended use, contraindications, precautions, and user instructions, must be provided in line with MDA’s labeling requirements.
  • Declaration of Conformity: A signed document by the manufacturer affirming that the device complies with Malaysian regulatory requirements.
  • Manufacturer’s Details: Information about the manufacturer, including the manufacturing site, production details, and any subcontracted processes, if applicable.

4. Local Authorized Representative (if required)

• For foreign manufacturers, appointing a local authorized representative in Malaysia is mandatory. This representative acts as the primary point of contact with MDA, manages the application process, and ensures compliance with regulatory requirements. They are responsible for ongoing regulatory obligations, including post-market surveillance and adverse event reporting.

5. Online Registration via MeDISS

• Register an account with the Medical Device Information and Safety System (MeDISS), MDA’s online portal for device registration.
• Complete the Class B registration application in MeDISS, uploading all required documentation in electronic format. Ensure that the application is accurate and comprehensive, as MDA may request additional information if anything is missing.

6. Registration Fees

• Pay the required fee for processing the Class B registration. The fee structure is specified in MDA’s guidelines and may vary depending on the type of device and complexity of the application.

7. Post-Market Requirements

• Adverse Event Reporting: Registered devices must comply with post-market surveillance, including reporting adverse events, device malfunctions, or any other issues impacting patient safety.
• Field Safety Corrective Actions (FSCA): Implement corrective actions if necessary, such as product recalls, updates to labeling, or device modifications.
• Device Renewal: Maintain an active registration by renewing it before expiration, typically every five years.

8. Additional Considerations

• Conformity Assessment by a Notified Body (if required): For some Class B IVDs, MDA may request an independent assessment of conformity by a third-party body to validate compliance with Malaysian regulatory standards.
• Compliance with Malaysian Standards (MS): Ensure the device meets Malaysian Standards or relevant international standards recognized by MDA.

By meeting these requirements, manufacturers can establish compliance and streamline the approval process for B-class IVD devices in Malaysia.