For Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), several international and local standards are applicable. These standards ensure that the device meets the safety, performance, and quality requirements necessary for approval. Here is an overview of the relevant standards that apply to the registration process:

1. International Standards

Hong Kong follows internationally recognized standards for medical device safety and performance. Key standards include:

ISO 13485:2016 – Medical Devices: Quality Management Systems

• ISO 13485 is a mandatory standard for the quality management system (QMS) for medical device manufacturers.

• It specifies the requirements for a comprehensive quality management system for the design, manufacture, and distribution of medical devices.

• Manufacturers must demonstrate that their QMS ensures consistent quality and compliance with both regulatory and customer requirements.

ISO 14971:2019 – Risk Management for Medical Devices

• ISO 14971 provides a framework for risk management throughout the entire lifecycle of a medical device.

• It helps manufacturers identify, assess, and control risks related to the device, ensuring that the residual risks are acceptable.

• For Class IV devices, which are high-risk, this standard is especially critical as it requires detailed documentation of risk analysis, risk controls, and post-market risk monitoring.

IEC 60601 Series – Medical Electrical Equipment

• IEC 60601 is a series of standards that apply to the safety and performance of electrical medical equipment.

• It addresses various requirements for electrical medical devices, including safety standards, electromagnetic compatibility (EMC), and functional performance.

• Depending on the nature of the Class IV device, compliance with relevant parts of IEC 60601 (e.g., IEC 60601-1 for basic safety and IEC 60601-1-2 for EMC) may be required.

ISO 10993 Series – Biological Evaluation of Medical Devices

• ISO 10993 provides guidelines for evaluating the biocompatibility of medical devices.

• Class IV medical devices, especially those that come into contact with the human body, must demonstrate that they do not pose any biological risks such as toxicity or allergic reactions.

• Relevant parts of the standard include tests for cytotoxicity, sensitization, irritation, and systemic toxicity.

IEC 62304:2006 – Software Life Cycle Processes

• If the Class IV medical device includes software, IEC 62304 applies to the development and maintenance of software used in medical devices.

• This standard specifies the processes, activities, and tasks required to ensure the safety and effectiveness of medical device software throughout its lifecycle.

ISO 14155:2020 – Clinical Investigation of Medical Devices

• ISO 14155 provides guidelines for clinical trials involving medical devices.

• For Class IV devices, which may require clinical evidence to demonstrate safety and performance, this standard outlines the protocols for designing, conducting, and reporting clinical investigations.

2. Local Standards in Hong Kong (MDACS)

Hong Kong MDACS recognizes and incorporates relevant international standards while also providing specific local regulations and guidelines for the approval of medical devices.

MDACS Guidelines

• MDACS Guidelines for Registration of Medical Devices:

  • These guidelines outline the registration process for medical devices in Hong Kong.

  • They detail the classification system for medical devices and the documentation required for each class.

  • Class IV devices, being high-risk, must meet the stringent safety and performance requirements laid out in these guidelines.

• Notification to Manufacturers:

  • The Hong Kong Department of Health periodically issues notifications and updates on the latest regulatory changes and expectations for manufacturers.

3. Other Relevant Standards

Depending on the device type, additional specific standards may apply, such as:

• ISO 13485 – For ensuring product safety and effectiveness throughout the lifecycle.

• ISO 18113 – Labels and Instructions for Use for In Vitro Diagnostic Devices (if applicable).

• IEC 62366 – Usability engineering for medical devices, focusing on human factors.

• ISO 10271 – Sterilization of medical devices.

• ISO 17665 – Sterilization by moist heat.

4. Hong Kong Regulatory Considerations

In addition to these international standards, manufacturers must also adhere to the Hong Kong-specific regulatory framework:

• The MDACS (Medical Device Administrative Control System) is used for registering medical devices in Hong Kong.

• The Hong Kong Department of Health oversees the registration process, which includes assessing conformity with relevant international standards.

• Local Responsible Person (LRP): In Hong Kong, foreign manufacturers must appoint an LRP to act as the point of contact with the local regulatory authorities.

Key Takeaways

• Class IV medical devices must meet stringent international standards such as ISO 13485, ISO 14971, IEC 60601, and ISO 10993, among others.

• Compliance with these standards ensures that the device is safe, effective, and manufactured according to best practices.

• Local regulations under MDACS must also be adhered to for device registration, and manufacturers must appoint a Local Responsible Person (LRP) in Hong Kong.

Would you like more details on any of these standards or assistance with any particular aspect of the registration process?

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