For Class II medical device MDACS registration in Hong Kong, the Medical Device Administrative Control System (MDACS) requires that medical devices comply with specific international standards to ensure their safety, efficacy, and quality. Below are the key standards that apply to Class II medical devices for MDACS registration:

1. ISO 13485:2016 (Quality Management Systems)

• ISO 13485 is a standard for quality management systems (QMS) specific to medical devices. It is a critical requirement for the manufacturing process, as it ensures that devices meet regulatory requirements and maintain high quality during production.

• Manufacturers seeking MDACS registration must demonstrate compliance with ISO 13485 for their manufacturing practices.

2. ISO 14971:2019 (Risk Management for Medical Devices)

• ISO 14971 outlines the process for risk management in the design and production of medical devices. It helps manufacturers identify potential hazards, assess risks, and implement risk controls to ensure patient and user safety.

• For Class II devices, the risk analysis process should be in line with ISO 14971 to mitigate risks and ensure that any identified risks are controlled throughout the lifecycle of the device.

3. IEC 60601 (Medical Electrical Equipment - Safety and Performance)

• For medical devices that are electrical in nature (e.g., diagnostic or therapeutic equipment), compliance with IEC 60601 is required. This standard sets the safety and performance requirements for electrical medical devices.

  • It includes requirements for electrical safety, electromagnetic compatibility, and performance testing.

  • The specific version required is usually IEC 60601-1, but other parts may be applicable depending on the device type.

4. ISO 10993 (Biological Evaluation of Medical Devices)

• ISO 10993 is crucial for devices that come into contact with human tissue or are intended for implantation (e.g., implants, surgical tools).

• The standard provides guidelines for biocompatibility testing to ensure that the materials used in the device do not cause harm to the user.

• Class II devices that involve direct or indirect contact with patients must comply with this standard and submit relevant biocompatibility test results.

5. ISO 15223-1:2021 (Symbols for Medical Devices)

• ISO 15223-1 provides symbols that should be used on medical device labeling to communicate information clearly to users without language barriers.

• This includes symbols for handling instructions, storage conditions, and device expiration dates, among other things.

• Compliance with this standard ensures that the labeling is clear, informative, and user-friendly.

6. ISO 14155:2020 (Clinical Investigation of Medical Devices)

• ISO 14155 covers the clinical investigation of medical devices, providing guidance on designing, conducting, and reporting clinical trials.

• While Class II devices may not always require clinical trials, if clinical data is required (e.g., novel devices or those without prior approval in other markets), this standard ensures the investigation is scientifically sound and ethically conducted.

7. IEC 62304 (Software Life Cycle Processes)

• If the medical device contains software (e.g., medical diagnostic equipment with embedded software), it must comply with IEC 62304, which outlines the requirements for software development life cycle processes in medical devices.

• This standard ensures that software development, validation, and maintenance processes are consistent with the device’s overall safety and effectiveness.

8. Good Manufacturing Practices (GMP)

• Although ISO 13485 covers many aspects of manufacturing, manufacturers are also expected to adhere to Good Manufacturing Practices (GMP), which are sometimes included in local regulations and international standards.

• GMP ensures that the manufacturing process consistently produces devices that are of the required quality.

9. FDA and CE Marking Compliance (International Approvals)

• If your device has been previously approved or cleared by FDA (U.S.) or received CE marking (EU), these certifications may serve as proof that the device meets international standards.

• MDACS recognizes these certifications as part of the conformity assessment process, but further evidence of compliance with Hong Kong’s regulatory requirements (such as ISO certifications) may still be necessary.

10. International Guidelines and Regulatory Requirements

• While MDACS registration focuses on local Hong Kong requirements, international guidelines such as those from the World Health Organization (WHO) or Global Harmonization Task Force (GHTF) may also influence compliance expectations for manufacturers.

11. MDACS-Specific Guidelines

• The MDCO (Medical Device Control Office) may issue specific guidelines or requirements that complement or specify particular aspects of these international standards for Class II devices in Hong Kong.

• These MDACS guidelines focus on local compliance with the Hong Kong Medical Device Ordinance and can be consulted for further clarity.

By ensuring that your Class II medical device complies with these international standards, you will meet the necessary regulatory requirements for MDACS registration in Hong Kong.

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