For Class C medical device registration with the Malaysian Medical Device Authority (MDA), manufacturers must adhere to specific standards that ensure the safety, effectiveness, and quality of the device. Here are the main standards and guidelines that apply to Class C devices:

1. Quality Management System (QMS) Standards

• ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  • This international standard specifies requirements for a quality management system (QMS) that demonstrates consistent design, development, production, and post-market processes for medical devices.
  • Certification to ISO 13485 by a recognized body is generally required, as it confirms that the manufacturer follows standardized quality practices.

2. Risk Management Standard

• ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices
  • This standard outlines the risk management framework, including processes for risk analysis, risk evaluation, risk control, and residual risk management.
  • A documented risk management report is essential to show that risks associated with the device have been identified, mitigated, and deemed acceptable for use.

3. Biocompatibility Standards (for Devices with Body Contact)

• ISO 10993 Series – Biological Evaluation of Medical Devices
  • The ISO 10993 standards series covers the biological evaluation of medical devices and includes testing for biocompatibility (e.g., cytotoxicity, sensitization, irritation).
  • These tests are crucial for any device that comes into contact with a patient’s body, as they ensure materials used are safe and compatible with human tissues.

4. Electrical Safety and Electromagnetic Compatibility (EMC) Standards (for Electrical Devices)

• IEC 60601 Series – Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance
  • This series is essential for electrically powered devices, covering requirements for electrical safety, performance, and EMC to prevent electrical hazards or malfunctions.
  • IEC 60601-1 addresses general safety, while IEC 60601-1-2 covers EMC requirements to ensure the device performs reliably in various environments.

5. Software Life Cycle Processes (for Devices with Software Components)

• IEC 62304:2006/Amd 1:2015 – Medical Device Software – Software Life Cycle Processes
  • This standard is applicable to devices with embedded or standalone software. It outlines software design, development, validation, and lifecycle management processes.
  • Compliance with IEC 62304 ensures the device software is reliable and safe for use, especially for devices where software plays a critical role in functionality.

6. Clinical Evidence and Evaluation Standards

• MEDDEV 2.7/1 Rev.4 – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies
  • The European MEDDEV guidelines are commonly accepted by MDA for clinical evaluations. This guidance covers requirements for clinical data, literature reviews, and post-market surveillance to demonstrate the device’s safety and performance.
• ISO 14155:2020 – Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice
  • For clinical studies conducted on the device, ISO 14155 provides requirements for study design, ethics, and data integrity to ensure compliance with Good Clinical Practice (GCP).

7. Sterility Standards (for Sterile Devices)

• ISO 11737 Series – Sterilization of Medical Devices
  • This series outlines requirements for validating sterilization processes, including bioburden testing, sterility assurance levels (SALs), and maintenance of sterility in packaging.
• ISO 14644 Series – Cleanrooms and Associated Controlled Environments
  • These standards apply to manufacturing environments where sterile devices are produced. They ensure cleanroom conditions to prevent contamination during production.

8. Labeling and Packaging Standards

• ISO 15223-1:2021 – Medical Devices – Symbols to be Used with Information to be Supplied by the Manufacturer
  • This standard specifies symbols used in medical device labeling, ensuring consistent information on safety, use, and restrictions.
• ISO 11607 Series – Packaging for Terminally Sterilized Medical Devices
  • For devices that require terminal sterilization, these standards cover packaging requirements to maintain sterility, integrity, and usability of the device until it is used.

9. Environmental and Biological Safety Standards (if applicable)

• ISO 14001:2015 – Environmental Management Systems – Requirements with Guidance for Use
  • For environmentally sensitive devices or those with disposable components, ISO 14001 can be relevant as it governs environmental impact and sustainability considerations.
• REACH and RoHS Compliance – For devices containing chemicals or electronics, the EU REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) and RoHS (Restriction of Hazardous Substances) standards may apply, ensuring limited exposure to hazardous materials.

10. Declaration of Conformity (DoC)

• Declaration of Conformity (DoC): A formal document prepared and signed by the manufacturer or an authorized representative, declaring that the device meets all applicable MDA standards and regulatory requirements.

Additional Guidance for Preparing Technical Documents

Following these standards and organizing technical documents according to MDA’s requirements can streamline the registration process and improve approval chances. For comprehensive guidance, consult MDA’s official guidelines on their website or work with a regulatory expert to ensure compliance with the latest standards.

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