When applying for B-class in vitro diagnostic (IVD) medical device registration with Malaysia's Medical Device Authority (MDA), specific technical document requirements must be fulfilled to demonstrate compliance, safety, and efficacy of the device. Here’s a detailed outline of the technical document requirements:

1. Device Description

• General Description: Provide an overview of the device, including its name, model, intended use, target population, and operating principles.
• Device Components: Detailed information about the device's components, materials, and any accessories included in the device system.

2. Risk Management Report

• ISO 14971 Compliance: Document the risk management process, identifying potential hazards associated with the device and the steps taken to mitigate these risks.
• Risk Analysis: Include a risk assessment table outlining identified risks, their likelihood, potential consequences, and the effectiveness of mitigation measures.
• Residual Risks: Address any residual risks that remain after implementing risk control measures, and justify their acceptability.

3. Performance Evaluation Data

• Clinical Data: Provide evidence from clinical studies or evaluations demonstrating the device's safety and effectiveness for its intended use.
• Non-Clinical Data: Include laboratory testing results and analytical performance data that validate the device's accuracy, precision, specificity, and sensitivity.
• Comparative Studies: If applicable, data comparing the device's performance to similar products or established standards.

4. Labeling and Instructions for Use (IFU)

• Labeling Information: Include the device's label with necessary information, such as the device name, intended use, instructions for use, storage conditions, and any relevant warnings or precautions.
• Instructions for Use: Provide a comprehensive IFU that outlines how to operate the device, interpret results, and includes information on maintenance, troubleshooting, and disposal.

5. Quality Management System (QMS) Documentation

• ISO 13485 Certification: Provide a copy of the ISO 13485 certification, demonstrating compliance with international standards for medical device quality management.
• QMS Manual: Include a brief description of the QMS structure, policies, and procedures relevant to the device's development and manufacturing.

6. Declaration of Conformity

• Compliance Statement: A formal document signed by the manufacturer or authorized representative affirming that the device complies with relevant Malaysian regulatory requirements and applicable standards.
• Reference Standards: Mention the specific standards or regulations to which the device conforms.

7. Manufacturer Information

• Company Profile: Provide details about the manufacturer, including the company name, address, and contact information.
• Manufacturing Locations: List all locations where the device is manufactured or assembled, including any third-party suppliers or subcontractors.

8. Post-Market Surveillance Plan

• Surveillance Activities: Outline plans for monitoring the device’s performance after market entry, including strategies for handling adverse events and feedback from users.
• Reporting Procedures: Include procedures for reporting adverse events to MDA and maintaining device safety and efficacy records.

9. Local Authorized Representative Information (if applicable)

• If the manufacturer is based outside Malaysia, provide details about the appointed local authorized representative, including their contact information and role in regulatory compliance.

Summary of Technical Document Requirements

1. Device Description
2. Risk Management Report
3. Performance Evaluation Data
4. Labeling and Instructions for Use (IFU)
5. Quality Management System (QMS) Documentation
6. Declaration of Conformity
7. Manufacturer Information
8. Post-Market Surveillance Plan
9. Local Authorized Representative Information (if applicable)

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