For B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, the device must meet various internationally recognized standards to ensure its safety, performance, and quality. These standards cover areas such as design, manufacturing, testing, risk management, and post-market surveillance.

Here are the key standards and requirements that a B-class medical device must comply with:

1. Quality Management System (QMS) Standards

• ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  • What It Covers: ISO 13485 is the international standard for quality management systems specific to medical devices. It outlines requirements for a manufacturer’s QMS, covering the entire lifecycle of the device, from design and development to production, installation, and servicing.
  • Importance for MDACS: The manufacturer must provide evidence of compliance with ISO 13485 (or equivalent) to demonstrate that the device is manufactured according to internationally recognized quality standards.

2. Risk Management Standards

• ISO 14971: Medical Devices – Application of Risk Management to Medical Devices
  • What It Covers: ISO 14971 provides a framework for identifying, evaluating, and controlling risks associated with medical devices throughout their lifecycle.
  • Importance for MDACS: Manufacturers must conduct a risk analysis and submit a Risk Management Report that demonstrates the device complies with ISO 14971, outlining potential risks, their severity, and how they have been mitigated.

3. Safety and Performance Standards

• Essential Principles of Safety and Performance
  • What It Covers: The Essential Principles are a set of safety and performance guidelines that medical devices must meet. They ensure the device is safe, performs as intended, and meets regulatory requirements.
  • Key Aspects:
    • Device Safety: The device should not pose any undue risk to patients or users when used as intended.
    • Performance: The device must perform according to its intended use and claims.
    • Chemical, Physical, and Biological Properties: The device must be made of biocompatible materials, especially if it comes into contact with the human body.
    • Electrical Safety (if applicable): Electrical medical devices must comply with electrical safety standards.
    • Sterility (if applicable): Sterile devices must meet sterilization and packaging standards.
  • Importance for MDACS: The manufacturer must declare that the device complies with the Essential Principles, and provide supporting data to verify compliance.

4. Testing Standards

Biocompatibility Testing Standards

• ISO 10993: Biological Evaluation of Medical Devices
  • What It Covers: ISO 10993 is a series of standards for evaluating the biocompatibility of medical devices that come into contact with the human body. It covers testing for:
    • Cytotoxicity (cell toxicity)
    • Sensitization
    • Irritation or intracutaneous reactivity
    • Systemic toxicity
    • Genotoxicity
    • Hemocompatibility (if the device interacts with blood)
  • Importance for MDACS: Devices that have patient contact must undergo biocompatibility testing according to ISO 10993. The test results must be submitted as part of the registration.

Electrical Safety and Electromagnetic Compatibility (EMC) Standards (for electronic devices)

• IEC 60601: Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance

  • What It Covers: IEC 60601 defines the safety and essential performance requirements for electrical medical equipment, focusing on patient and user safety.
  • Importance for MDACS: If your device is electrically powered or emits electromagnetic fields, you must demonstrate compliance with IEC 60601. This includes testing for electrical safety, EMC, and performance reliability.

• IEC 61010: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

  • What It Covers: This standard applies to devices used in laboratories, diagnostic settings, or for measurement and control purposes, ensuring they meet electrical safety requirements.
  • Importance for MDACS: If your device fits into these categories, compliance with IEC 61010 is required.

5. Sterilization Standards (if applicable)

• ISO 11135: Sterilization of Health Care Products – Ethylene Oxide

  • What It Covers: This standard provides requirements for the sterilization of medical devices using ethylene oxide, a common sterilization method for heat-sensitive devices.
  • Importance for MDACS: For devices that must be sterile (e.g., surgical instruments, implants), compliance with ISO 11135 is necessary if ethylene oxide sterilization is used.

• ISO 17665: Sterilization of Health Care Products – Moist Heat

  • What It Covers: This standard covers the sterilization of medical devices using moist heat, such as autoclaving.
  • Importance for MDACS: Compliance is required if moist heat sterilization is used.

6. Clinical Evaluation Standards

• MEDDEV 2.7/1: Clinical Evaluation – A Guide for Manufacturers and Notified Bodies
  • What It Covers: This guideline outlines the process for conducting clinical evaluations of medical devices to prove their safety and performance based on clinical data.
  • Importance for MDACS: A Clinical Evaluation Report (CER) must be submitted to the MDCO, either based on new clinical trials or an assessment of existing scientific literature.

7. Software Standards (if applicable)

• IEC 62304: Medical Device Software – Software Life Cycle Processes
  • What It Covers: IEC 62304 defines the life cycle requirements for the development and maintenance of medical device software.
  • Importance for MDACS: For medical devices that include software (e.g., diagnostic systems, monitoring devices), compliance with IEC 62304 is essential. This standard ensures that the software is designed, tested, and maintained safely throughout its lifecycle.

8. Labeling and User Information Standards

• ISO 15223: Medical Devices – Symbols to Be Used with Medical Device Labels, Labelling and Information to Be Supplied
  • What It Covers: This standard specifies symbols and labeling requirements that are internationally recognized for medical devices.
  • Importance for MDACS: Labels, packaging, and Instructions for Use (IFU) must comply with ISO 15223 to ensure that users can clearly understand how to use the device and be aware of any warnings or precautions.

9. Post-Market Surveillance (PMS) Standards

• ISO/TR 20416: Medical Devices – Post-Market Surveillance for Manufacturers
  • What It Covers: This technical report provides guidance on post-market surveillance activities to monitor the performance of a medical device once it has been placed on the market.
  • Importance for MDACS: The manufacturer must submit a Post-Market Surveillance Plan as part of the application, detailing how the device’s safety and performance will be monitored after it is approved for use.

Summary of Key Standards for B-Class Medical Device MDACS Registration

1. ISO 13485: Quality management system for medical device manufacturing.
2. ISO 14971: Risk management framework for medical devices.
3. Essential Principles: Compliance with safety, performance, and labeling requirements.
4. ISO 10993: Biocompatibility testing for devices in contact with the body.
5. IEC 60601 / IEC 61010: Electrical safety and electromagnetic compatibility for electrical devices.
6. ISO 11135 / ISO 17665: Sterilization standards for ethylene oxide or moist heat sterilization.
7. MEDDEV 2.7/1: Clinical evaluation process for proving safety and performance.
8. IEC 62304: Software lifecycle processes for medical device software.
9. ISO 15223: Labeling and symbols for medical devices.
10. ISO/TR 20416: Post-market surveillance plan for ongoing safety and performance monitoring.