For Class D medical device registration with the Medical Device Authority (MDA) in Malaysia, several standards must be adhered to in order to demonstrate the safety, efficacy, and quality of the device. Here are the key standards relevant to Class D medical devices:

1. ISO 13485:

• Quality Management Systems: This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

2. ISO 14971:

• Risk Management: This standard provides a framework for the risk management process in medical devices, including risk analysis, evaluation, control, and monitoring throughout the product lifecycle.

3. IEC 60601 Series:

• Electrical Safety and Performance: These standards relate to the safety and effectiveness of medical electrical equipment. Compliance ensures that devices are safe for both patients and operators and perform as intended.

4. ISO 14155:

• Clinical Investigations: This standard outlines the good clinical practice for conducting clinical investigations of medical devices, ensuring the protection of human subjects and the credibility of clinical data.

5. ISO 10993:

• Biocompatibility: This series of standards assesses the biocompatibility of medical devices with respect to their materials. It includes testing for cytotoxicity, sensitization, irritation, and other biological responses.

6. ISO 7000:

• Graphical Symbols for Use in the Labeling of Medical Devices: This standard provides graphical symbols that can be used on labels and in the instructions for use to convey information to users.

7. MDA Technical Guidance Documents:

• The MDA also publishes technical guidance documents that outline specific requirements for different types of medical devices. These documents provide additional context and requirements that must be followed.

8. Good Manufacturing Practices (GMP):

• Compliance with GMP is essential for the manufacturing processes of medical devices, ensuring products are consistently produced and controlled according to quality standards.

Additional Considerations:

• National and Regional Regulations: In addition to the above international standards, manufacturers must also comply with any specific Malaysian regulations and guidelines set forth by the MDA.

By adhering to these standards, manufacturers can ensure that their Class D medical devices are safe, effective, and compliant with regulatory requirements in Malaysia.

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