For Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), several international standards are referenced to ensure that devices are safe, effective, and meet regulatory requirements. These standards guide the design, manufacturing, risk management, and performance of medical devices, and while they are not legally required for all Class I devices, compliance with them is highly encouraged.

Here are the key standards and guidelines relevant for Class I IVD device registration under MDACS:

1. ISO 13485:2016 - Medical Devices – Quality Management Systems

• This is the international standard that specifies the requirements for a quality management system (QMS) for medical device manufacturers.
• ISO 13485 outlines the processes for ensuring that medical devices consistently meet customer and regulatory requirements.
• While not mandatory for Class I IVD devices, manufacturers that are ISO 13485 certified provide assurance that they adhere to quality practices and systems to ensure device safety and performance.

2. ISO 14971:2019 - Medical Devices – Application of Risk Management to Medical Devices

• ISO 14971 provides a systematic approach to managing risks throughout the life cycle of a medical device.
• This standard applies to the identification, assessment, control, and monitoring of risks associated with medical devices, including IVDs. It helps manufacturers ensure the safety of the device by identifying hazards and minimizing risks.
• For Class I IVD devices, this standard is important to demonstrate that potential risks (e.g., contamination, false readings) have been considered and mitigated.

3. ISO 18113-1:2011 - In Vitro Diagnostic Medical Devices – Information Supplied by the Manufacturer – Part 1: Labels for In Vitro Diagnostic Medical Devices

• This standard outlines the labeling requirements for IVD devices, including what information must be provided on labels and packaging.
• Labeling should include details such as:
  • Manufacturer name and contact information.
  • Intended use and purpose.
  • Warnings, contraindications, and limitations.
  • Expiry date (if applicable) and storage conditions.
  • Instructions for use (IFU).

Compliance with this standard ensures that the device is labeled properly and provides users with sufficient information to use the device safely.

4. ISO 20916:2019 - In Vitro Diagnostic Medical Devices – Performance Evaluation

• This standard is applicable for the performance evaluation of IVD devices, ensuring that the device performs as intended under the specified conditions.
• For Class I IVDs, manufacturers should demonstrate that their devices meet the necessary performance criteria, including:
  • Accuracy, precision, sensitivity, specificity, and reliability.
  • Validation of the diagnostic method (e.g., test reliability in clinical settings).

5. IEC 61010-1:2010 - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use

• This standard applies to electrical IVD devices used for diagnostic testing and sets the safety requirements for electrical equipment.
• It ensures that electrical IVD devices are designed to prevent electrical hazards during use, such as short circuits, electric shocks, and fire risks.
• While Class I IVD devices are generally lower risk, if the device has electrical components, this standard helps ensure electrical safety.

6. ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects

• This standard governs the clinical investigation of medical devices, including Class I IVDs that may require clinical data to demonstrate their performance.
• It covers the design, conduct, and reporting of clinical studies to ensure that the device is tested appropriately in real-world conditions.
• Although clinical trials are often not required for Class I IVDs, if clinical data is used, adherence to this standard is essential.

7. ISO 13485:2016 - Medical Devices - Quality Management Systems

• As mentioned earlier, ISO 13485 provides guidelines for quality management systems (QMS) to ensure that medical devices are produced consistently in accordance with safety and performance requirements.
• A robust QMS helps the manufacturer to ensure compliance with regulatory standards and to ensure that products are manufactured with proper controls and that they perform as expected.

8. Other Standards for Specific Device Types

• Depending on the specific type of Class I IVD device, there may be other standards applicable. For example:
  • ISO 15197 for glucose monitoring devices.
  • ISO 22870 for POCT (Point-of-care testing) devices.
  • ASTM or CLSI standards for certain test methods and performance evaluations used in diagnostic kits.

Key Regulatory Guidelines and Compliance

In addition to the standards listed above, Hong Kong’s MDACS often refers to guidance documents from international regulatory bodies, such as:

• World Health Organization (WHO)
• European Medicines Agency (EMA)
• U.S. Food and Drug Administration (FDA)
• International Medical Device Regulators Forum (IMDRF)

These guidelines help define how medical devices, including Class I IVDs, should be evaluated for safety, effectiveness, and regulatory compliance.

Conclusion

The regulatory standards for Class I IVD device registration under Hong Kong MDACS focus on ensuring the quality, safety, performance, and risk management of devices. Adherence to standards such as ISO 13485, ISO 14971, and ISO 20916 is essential to demonstrate that the device meets both local and international regulatory requirements. Additionally, manufacturers must ensure compliance with labeling, clinical investigation guidelines, and specific standards based on the device type to support its safe and effective use in the market.