The standards for Class I medical device MDACS registration in Hong Kong are designed to ensure that medical devices meet the necessary safety, performance, and regulatory requirements for use in the Hong Kong market. These standards align with international practices and are largely based on existing global frameworks for medical devices, such as those set by the World Health Organization (WHO) and International Organization for Standardization (ISO).

Key Standards for Class I Medical Device MDACS Registration in Hong Kong

1. ISO 13485:2016 - Quality Management Systems (QMS)

• ISO 13485 is an essential standard for manufacturers of medical devices. It specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

• For Class I devices, manufacturers must have an established QMS that is consistent with ISO 13485 to ensure that their products are made in a controlled environment, with sufficient processes to manage risks and ensure product quality.

2. ISO 14971:2019 - Risk Management for Medical Devices

• ISO 14971 outlines the requirements for a risk management process for medical devices. It helps manufacturers identify, assess, control, and monitor risks throughout the lifecycle of the device.

• Even though Class I devices are considered low-risk, manufacturers must still conduct a risk assessment in compliance with this standard to identify potential hazards and implement risk control measures.

3. IEC 60601 Series - Electrical Safety (for electrical devices)

• For electrical Class I medical devices, compliance with the IEC 60601 series is required. This series addresses electrical safety and performance standards for medical devices, ensuring that electrical medical devices are safe for use in clinical environments.

• If your device involves electrical components or power supply (e.g., therapeutic devices, diagnostic devices like ECGs), it must meet the specific requirements of the relevant IEC 60601 standard for electrical safety.

4. ISO 10993 - Biological Evaluation of Medical Devices

• ISO 10993 provides guidelines for evaluating the biological safety of medical devices, especially those in direct or indirect contact with the body.

• Even though Class I devices are low-risk, if your device involves materials that come in contact with the skin or body (e.g., bandages, sensors), you must ensure that it meets the biological evaluation requirements to demonstrate that it does not cause adverse reactions.

5. ISO 15223-1:2021 - Symbols for Medical Device Labeling

• ISO 15223-1 defines the symbols that must appear on the labeling of medical devices, providing universal icons to convey important safety, operational, and usage information.

• The labeling for your Class I medical device must adhere to these standards to ensure that it is understandable to healthcare providers and patients, and to avoid misinterpretation.

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

• Although typically not required for Class I devices, ISO 14155 outlines the standards for conducting clinical investigations on medical devices.

• If your Class I device involves clinical claims or requires clinical evidence for registration (e.g., monitoring or diagnostic devices), it may need to comply with the requirements of ISO 14155 for clinical trials and investigations.

7. Hong Kong Medical Device Regulations

• The Hong Kong Medical Device Ordinance (Cap. 599) is the key regulatory framework governing the sale, importation, and manufacture of medical devices in Hong Kong. It establishes the regulatory requirements for medical devices, including registration, post-market surveillance, and quality management.

• MDACS (Medical Device Administrative Control System) is the system used to register medical devices in Hong Kong. Class I medical devices follow the simpler registration process under MDACS but must still comply with the overarching requirements set by the Medical Device Ordinance.

8. Good Manufacturing Practice (GMP)

• In addition to the aforementioned standards, adherence to Good Manufacturing Practice (GMP) is critical to ensure that medical devices are consistently produced and controlled according to quality standards.

• GMP includes guidelines on manufacturing processes, production environment, storage, and handling of devices to ensure their safety and quality throughout the production cycle.

9. IEC 62366 - Usability Engineering for Medical Devices

• IEC 62366 provides guidelines for usability engineering, which is essential for ensuring that medical devices are designed and tested for ease of use, with particular attention to the risk of user errors.

• This standard is especially relevant for devices where user interface and usability could directly impact patient safety and device performance.

General Process for Compliance

1. Ensure Device Classification: Confirm that your device qualifies as a Class I medical device under Hong Kong’s regulations.

2. Prepare Documentation: Prepare the required technical documentation that complies with the standards above (e.g., risk assessments, conformity to ISO standards).

3. Labeling and Packaging: Ensure your device labeling complies with ISO 15223-1, including relevant symbols and usage instructions.

4. Submit Registration Application: Use the MDACS portal to submit your application, including the necessary documents to the Department of Health.

Conclusion

For Class I medical device MDACS registration in Hong Kong, manufacturers must comply with international standards like ISO 13485, ISO 14971, and IEC 60601, in addition to Hong Kong’s local regulatory framework. Ensuring that your device meets these standards will help facilitate a smooth registration process and ensure that it complies with the safety, performance, and regulatory requirements necessary for approval in Hong Kong.

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