To obtain Class D medical device registration with the Medical Device Authority (MDA) in Malaysia, you must meet several specific requirements, given the high-risk nature of these devices. Here are the key requirements:

1. Device Classification:

• Confirm that your device is classified as Class D according to MDA classification criteria.

2. Technical Documentation:

• Device Description: Detailed description of the device, its intended use, and indications.
• Risk Management File: Comprehensive risk assessment following ISO 14971, detailing potential hazards and risk mitigation measures.
• Clinical Evaluation Report: Evidence of clinical data demonstrating the device's safety and efficacy. This may include clinical trials, literature reviews, and other relevant studies.
• Quality Management System (QMS): Documentation proving compliance with ISO 13485, which should include manufacturing processes and quality assurance measures.

3. Labeling and Packaging:

• Provide samples or detailed descriptions of labeling, including instructions for use, safety information, and regulatory compliance statements.

4. Manufacturing Information:

• Details of the manufacturing process, including facilities, equipment, and quality control measures.

5. Compliance with Standards:

• Ensure compliance with relevant national and international standards applicable to medical devices, such as electrical safety standards (if applicable).

6. Declaration of Conformity:

• A statement from the manufacturer declaring that the device meets all applicable regulatory requirements.

7. Registration Application:

• Submit an application through the MDA's online registration system, providing all required documentation and paying the necessary fees.

8. Post-Market Surveillance Plan:

• Outline a plan for monitoring the device's performance and safety post-market, including how to handle adverse events and reports.

9. Local Representation (if applicable):

• If the manufacturer is not based in Malaysia, a local authorized representative may be required to facilitate communication with the MDA.

Additional Considerations:

• Consultation: It may be beneficial to consult with regulatory experts familiar with the MDA’s requirements to ensure all documentation is complete and compliant.
• Updates: Regularly check the MDA’s official website for any changes in regulations or additional requirements.

Meeting these requirements will help facilitate the registration process for Class D medical devices in Malaysia.

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