For Class III medical device MDACS registration in Hong Kong, there are several key international standards and regulatory requirements that the medical device must comply with. These standards ensure the safety, performance, and quality of the device throughout its lifecycle—from development to post-market surveillance.

Here’s a summary of the main standards that apply:

1. International Standards for Medical Devices

The device should meet internationally recognized standards, such as:

ISO 13485:2016 – Quality Management Systems

• ISO 13485 sets the requirements for a quality management system (QMS) specific to the medical device industry.

• It ensures that the manufacturer follows proper processes in design, manufacturing, and post-market surveillance to ensure the safety and effectiveness of the medical device.

ISO 14971:2019 – Risk Management for Medical Devices

• This standard outlines the risk management process for medical devices, including risk analysis, risk evaluation, and risk control.

• Manufacturers must identify and mitigate potential hazards associated with the device, ensuring patient and user safety.

IEC 60601 Series – Medical Electrical Equipment

• IEC 60601 is a set of standards that apply to electrical medical devices.

• It provides guidelines for the safety and essential performance of medical electrical equipment, including aspects like electrical safety, electromagnetic compatibility, and environmental performance.

ISO 14155:2020 – Clinical Investigation of Medical Devices for Human Subjects

• ISO 14155 provides guidelines for the clinical evaluation and trials of medical devices, including protocols for conducting clinical investigations.

• It ensures that the clinical trials for Class III devices are ethically conducted and that the results contribute to the safety and performance evaluation.

ISO 10993 Series – Biological Evaluation of Medical Devices

• This series of standards provides guidelines for biological testing of medical devices.

• It includes testing for cytotoxicity, sensitization, and irritation to evaluate the biocompatibility of the materials used in the device.

2. Hong Kong Specific Regulatory Standards

Although Hong Kong follows international standards, there are certain regulatory requirements under the Hong Kong Medical Device Ordinance (Cap. 599) and MDACS that must be adhered to for Class III medical device registration.

Medical Device Ordinance (Cap. 599)

• This ordinance governs the safety, efficacy, and quality of medical devices in Hong Kong.

• It mandates that medical devices, especially those classified as Class III (high-risk devices), must meet specific safety and performance criteria before they can be legally marketed in Hong Kong.

MDACS (Medical Device Administrative Control System)

• MDACS provides the administrative framework for medical device registration in Hong Kong.

• It establishes the regulatory requirements for manufacturers and importers to ensure that their devices meet international standards and are safe for use in Hong Kong.

3. Relevant Standards for Specific Device Types

Depending on the type of Class III medical device (e.g., implantable devices, life-supporting devices), additional specific standards might apply:

ISO 13485:2016 for Software in Medical Devices

• If the Class III device includes software (e.g., diagnostic software, programmable medical equipment), ISO 13485 requirements for software validation and risk management should be followed.

• The software should comply with the standards set in IEC 62304, which provides lifecycle requirements for medical device software.

ISO 22716:2007 – Good Manufacturing Practices for Cosmetics (if applicable for cosmetic medical devices)

• For certain cosmetic medical devices (e.g., dermal fillers or laser devices), standards related to manufacturing and safety in cosmetic products may apply.

4. Global Regulatory Standards

Hong Kong recognizes medical device registrations from other prominent regulatory bodies (EU, USA, Canada, Australia), so devices that are CE-marked, FDA-approved, or registered in Australia and Canada must also comply with the following global standards:

European Union (EU)

• Medical Device Regulation (MDR) 2017/745: For devices marketed in the EU, manufacturers must comply with the MDR to demonstrate that the device is safe and effective for its intended use.

• CE Marking: The CE mark on a device indicates that it meets all the essential requirements of the MDR, including safety, performance, and clinical evaluation.

United States (FDA)

• FDA 21 CFR Part 820: This part of the Code of Federal Regulations applies to the quality system requirements for medical devices marketed in the United States.

• FDA Premarket Approval (PMA) or 510(k) for Class III devices.

Australia (TGA)

• Therapeutic Goods Administration (TGA): The TGA enforces the Australian Register of Therapeutic Goods (ARTG) and ensures devices meet safety and quality requirements.

5. Standards for Specific Use Cases

For specific device types (e.g., in vitro diagnostic devices, implantable devices), certain standards may apply, such as:

• ISO 17511:2003 – In vitro diagnostic devices, specifying metrological traceability of measurements.

• ISO 27447:2019 – Active implantable medical devices.

Summary of Key Standards:

1. ISO 13485:2016 – Quality Management System for medical devices.

2. ISO 14971:2019 – Risk management for medical devices.

3. IEC 60601 Series – Electrical safety and performance standards.

4. ISO 14155:2020 – Clinical investigation and trials for medical devices.

5. ISO 10993 Series – Biological evaluation for medical devices.

6. ISO 22716:2007 – Good manufacturing practices for certain cosmetic medical devices.

7. Medical Device Ordinance (Cap. 599) – Regulatory framework specific to Hong Kong.

8. MDACS – Administrative framework for medical device registration in Hong Kong.

9. EU MDR and FDA regulations – If applicable to device approval in other jurisdictions.

By adhering to these standards, manufacturers ensure that their Class III medical devices meet the safety, performance, and quality requirements for MDACS registration in Hong Kong. If you need further clarification on any particular standard, feel free to ask!

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