For Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS), various international and local standards apply to ensure the safety, effectiveness, and quality of the device. Below are the key standards and regulations that manufacturers must adhere to for successful registration:

1. ISO 13485: Quality Management System

• Purpose: This standard outlines the requirements for a quality management system (QMS) for manufacturers of medical devices.

• Application: It ensures that the device manufacturer has a robust quality management system in place, including processes for design, production, and post-market activities.

• Requirement: Manufacturers must have a certified ISO 13485 system to demonstrate their ability to produce medical devices that meet regulatory requirements and customer expectations.

2. ISO 14971: Risk Management for Medical Devices

• Purpose: This standard provides guidelines for the risk management process for medical devices.

• Application: It outlines the necessary steps for identifying, evaluating, controlling, and monitoring risks associated with medical devices.

• Requirement: A risk management file must be submitted, documenting the manufacturer's approach to ensuring the safety of the device throughout its lifecycle.

3. ISO 14155: Clinical Investigation of Medical Devices

• Purpose: ISO 14155 specifies the requirements for the design, conduct, and reporting of clinical trials and evaluations of medical devices.

• Application: It ensures that clinical data used to support the device’s safety and efficacy complies with international best practices.

• Requirement: Clinical data or evidence of clinical evaluation must be submitted for Class IV devices, which typically require a higher level of clinical scrutiny due to their complexity and potential risks.

4. ISO 10993: Biological Evaluation of Medical Devices

• Purpose: This series of standards provides guidelines for evaluating the biocompatibility of medical devices.

• Application: Devices that come into contact with the human body must undergo biological testing to ensure that they do not cause adverse reactions.

• Requirement: Depending on the nature of the device, relevant tests (e.g., cytotoxicity, sensitization, irritation) must be performed, and the results should be included in the registration application.

5. IEC 60601: Medical Electrical Equipment (Safety & EMC Standards)

• Purpose: This standard defines the safety and performance requirements for medical electrical equipment and systems.

• Application: If the Class IV device is electrically powered, it must meet safety and electromagnetic compatibility (EMC) standards.

• Requirement: The device must undergo testing for electrical safety and EMC in compliance with IEC 60601-1, as well as its related parts (e.g., IEC 60601-1-2 for EMC).

6. IEC 62304: Medical Device Software – Software Lifecycle Processes

• Purpose: This standard applies to software used in medical devices, ensuring that software development processes follow strict guidelines for safety and effectiveness.

• Application: For devices with embedded software, compliance with IEC 62304 is essential to demonstrate the safe development, validation, and lifecycle management of the software.

• Requirement: Documentation should show how the software was designed, developed, and validated in line with this standard.

7. ISO 15223: Symbols for Medical Devices

• Purpose: This standard specifies the symbols used on medical device labels and instructions for use (IFU) to ensure clear communication of important information.

• Application: Symbols are used on packaging and labeling to convey essential information such as warnings, storage conditions, and instructions for use.

• Requirement: The device labels must include standardized symbols as per ISO 15223, and IFUs must be clear and comprehensible.

8. ISO 14160: Sterilization of Medical Devices

• Purpose: ISO 14160 provides guidelines for sterilization of medical devices using ethylene oxide.

• Application: If the device is sterilized using ethylene oxide, the manufacturer must demonstrate that sterilization processes meet ISO 14160.

• Requirement: Documentation of sterilization validation and process controls must be provided if applicable.

9. Good Manufacturing Practice (GMP)

• Purpose: GMP standards ensure that devices are consistently produced and controlled according to quality standards.

• Application: The device manufacturer must adhere to GMP guidelines, which apply to all aspects of production, from raw material sourcing to finished product release.

• Requirement: The manufacturer must provide documentation of GMP compliance, which may be verified by regulatory authorities during inspections.

10. Local Hong Kong Requirements and Regulations

• Purpose: In addition to international standards, manufacturers must comply with local Hong Kong regulations for medical devices, which are overseen by the Department of Health.

• Application: This includes the submission of appropriate application forms, proof of compliance with local regulations, and registration with the Hong Kong MDACS system.

• Requirement: Devices must meet local safety and efficacy standards and comply with Hong Kong's requirements for the medical device classification, labeling, and post-market surveillance.

Summary of Key Standards for Class IV Medical Device Registration under MDACS

Conclusion

For Class IV medical device registration under Hong Kong MDACS, manufacturers must adhere to a comprehensive set of international and local standards covering quality management, risk management, clinical data, electrical safety, software, biocompatibility, and sterilization. Ensuring full compliance with these standards is critical to obtaining approval for marketing the device in Hong Kong.

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