For Class C medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), the medical device must comply with certain international standards to ensure safety, efficacy, and quality. These standards form the foundation for the conformity assessment process and provide evidence that the device meets regulatory requirements. Here are the key standards and regulations that apply to Class C devices:

Key Standards for Class C Medical Device Registration

1. ISO 13485: Quality Management System (QMS) for Medical Devices

• ISO 13485 is an international standard for the quality management system specific to medical device manufacturing.
• Requirement:
  • The manufacturer of the Class C medical device must demonstrate compliance with ISO 13485 or an equivalent standard, which ensures that the device is consistently designed, developed, produced, and maintained to meet regulatory standards.
  • The QMS should cover areas such as risk management, design control, product realization, and corrective actions.

2. ISO 14971: Risk Management for Medical Devices

• ISO 14971 is the international standard for risk management related to medical devices.
• Requirement:
  • A Risk Management Report is required as part of the technical documentation. This report should outline the process of identifying hazards, estimating and evaluating associated risks, controlling those risks, and monitoring the effectiveness of risk control measures.
  • The manufacturer must continuously evaluate and manage risks throughout the lifecycle of the device.

3. IEC 60601: Electrical Safety Standards for Medical Electrical Equipment

• IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment.
• Requirement:
  • For electrical or electro-medical devices, compliance with IEC 60601-1 (General requirements for basic safety and essential performance) and applicable parts of the IEC 60601 series is required.
  • This ensures that the device meets electrical safety and performance standards.

4. ISO 10993: Biological Evaluation of Medical Devices

• ISO 10993 is a set of standards for evaluating the biocompatibility of medical devices that come into contact with the human body.
• Requirement:
  • If the Class C device is invasive or comes into direct or indirect contact with the body, biocompatibility testing according to ISO 10993 is required.
  • Testing should cover areas such as cytotoxicity, sensitization, irritation, and systemic toxicity to ensure that the materials used in the device are safe for their intended use.

5. ISO 14155: Clinical Investigation of Medical Devices for Human Subjects

• ISO 14155 outlines the good clinical practice standards for conducting clinical investigations on medical devices.
• Requirement:
  • Clinical trials and studies must be conducted in compliance with ISO 14155. This ensures that clinical data supporting the device’s safety and effectiveness are gathered in a controlled and ethical manner.
  • Proper documentation of clinical investigations is required as part of the Clinical Evidence submission.

6. CE Marking and FDA Approval

• CE Marking (Europe) and FDA Approval (USA) are recognized international regulatory approvals that provide evidence of a device’s conformity to specific safety and performance standards.
• Requirement:
  • The MDCO (Medical Device Control Office) accepts regulatory approvals from recognized jurisdictions, such as the European Union (CE marking) or the US FDA. These approvals can be submitted as part of the conformity assessment to demonstrate compliance with recognized international standards.

7. Essential Principles of Safety and Performance (MDACS)

• The Essential Principles of Safety and Performance is a set of regulatory requirements established by MDACS, derived from international guidelines.
• Requirement:
  • Applicants must demonstrate that the Class C device complies with these principles, which include requirements related to:
    • Performance of the device according to its intended use.
    • Safety during use, storage, and transport.
    • Minimization of risks (e.g., mechanical, electrical, biological).
    • Effective labeling and provision of information to users and patients.
  • A completed Essential Principles Checklist must be submitted with the application.

Additional Standards for Specific Devices

• Depending on the specific type of Class C device, additional standards may apply. For example:
  • ISO 14630 for non-active surgical implants.
  • ISO 25539 for cardiovascular implants (e.g., stents).
  • ISO 4074 for sterile medical devices (e.g., surgical gloves, syringes).
  • IEC 62304 for medical device software.

Compliance and Certification

• Testing and Certification Bodies: Device testing and certification should be performed by accredited laboratories or notified bodies recognized under international frameworks such as the International Medical Device Regulators Forum (IMDRF) or European Union (EU).
• Documentation: All standards compliance must be documented and submitted as part of the technical documentation for MDACS registration. Certification copies, test reports, and declarations of conformity to relevant standards are required.

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