Registering a D-class medical device in Malaysia involves a structured process regulated by the Medical Device Authority (MDA). Here’s a comprehensive guide to the process and steps involved:

1. Pre-Registration Preparation

Confirm Device Classification

• Determine Classification: Verify that the device is correctly classified as a D-class (high-risk) medical device based on the MDA classification criteria.
• Consult Guidelines: Review the MDA classification guidelines or seek advice from a regulatory consultant if needed.

Quality Management System (QMS)

• ISO 13485 Certification: Implement a QMS in compliance with ISO 13485. This certification demonstrates adherence to quality standards required for manufacturing and managing medical devices.
• Document Control: Ensure all QMS documentation, such as SOPs and quality manuals, is complete and up-to-date.

Technical Documentation

• Device Description: Prepare detailed documentation including device specifications, design, and intended use.
• Risk Management: Develop a Risk Management Report following ISO 14971.
• Clinical Evaluation: Compile clinical data supporting the safety and effectiveness of the device.
• Biocompatibility and Testing: Include results from biocompatibility testing (e.g., ISO 10993) and other relevant performance tests.
• Software Validation: If applicable, include documentation for software validation according to IEC 62304.

Authorized Representative (AR)

• Appointment: If the manufacturer is foreign, appoint a Malaysian Authorized Representative (AR) to handle regulatory matters.
• AR License: Ensure the AR holds a valid Establishment License issued by the MDA.

2. Application Submission

Prepare Application Documents

• Compile Documentation: Gather all required documents including technical documentation, QMS certification, clinical evaluation, risk management files, labeling, and instructions for use (IFU).
• Application Form: Complete the application form available on the MeDC@St online system.

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