For Class A medical device registration under Hong Kong's MDACS (Medical Device Administrative Control System), while the regulatory requirements are generally simpler for low-risk devices, there are still important standards that may apply to ensure that devices meet safety, quality, and performance criteria.

Here are the key standards and guidelines related to Class A medical devices under MDACS:

1. MDACS Regulatory Framework and Guidance

• MDACS (Medical Device Administrative Control System) itself provides the regulatory framework for medical device registration in Hong Kong. The MDACS Guideline (GN-01) is the primary document for device classification and regulatory procedures. This guideline helps manufacturers and distributors determine the appropriate classification of their devices (e.g., Class A) and provides insight into the specific regulatory requirements.

2. International Standards (Voluntary but Recommended)

Although not strictly required for Class A devices, international standards are encouraged and can be helpful in demonstrating compliance with safety and performance requirements:

ISO 13485:2016 - Quality Management Systems

• This is the standard for quality management systems that is widely recognized in the medical device industry.

• ISO 13485 is not mandatory for Class A devices under MDACS, but compliance with it can help ensure that the manufacturer has a robust quality management system in place, which may facilitate market acceptance and regulatory approvals.

ISO 14971:2019 - Risk Management for Medical Devices

• While it is not required for Class A devices, ISO 14971 outlines a systematic approach to managing risks associated with medical devices.

• Manufacturers may choose to follow this standard to ensure that their device is designed and produced with adequate risk mitigation measures.

ISO 10993 Series - Biological Evaluation of Medical Devices

• This standard series is focused on biological evaluation of medical devices, particularly for devices that come into contact with the body.

• For Class A devices, this may not be as relevant because most Class A devices are non-invasive. However, in some cases, manufacturers may still choose to demonstrate compliance with biological safety aspects.

3. Hong Kong Specific Standards and Guidelines

Class A Device Classification (MDACS Guidance)

• The Hong Kong government provides a classification system through MDACS, specifically Guideline GN-01, that outlines the criteria for Class A devices. This includes:

  • Non-invasive devices.

  • Devices that pose minimal risk to users or patients.

  • Devices that are non-sterile, non-measuring, and non-implantable.

These guidelines form the foundation for device classification and the registration process for Class A devices under MDACS.

4. Product Safety Standards (Optional but Beneficial)

If a device complies with certain product safety standards, this can help demonstrate that the device meets both safety and performance criteria. Some relevant standards for Class A medical devices include:

IEC 60601-1:2012 - Medical Electrical Equipment

• Although Class A devices are typically non-electrical, if the device has electrical components, compliance with IEC 60601-1 (Medical Electrical Equipment) is important to demonstrate electrical safety.

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

• Similar to IEC 60601-1, if the Class A medical device involves electrical components for control or measurement, compliance with IEC 61010-1 might be relevant.

5. Labeling and Documentation Standards

For Class A medical devices, the Hong Kong MDACS also sets specific labeling requirements under the Medical Device Ordinance. These labeling requirements align with international expectations for device identification, usage instructions, and safety warnings:

• ISO 15223-1:2016 - Symbols to be Used with Medical Device Labels, Labeling, and Information to be Supplied

• ISO 20417:2021 - Medical Devices – Information to be Provided by the Manufacturer: This standard sets out the labeling requirements for medical devices, which may include user manuals, warnings, and symbols.

6. Post-Market Surveillance Standards (Optional but Recommended)

While not required for Class A devices, manufacturers may wish to follow certain post-market surveillance procedures:

ISO 14155:2020 - Clinical Investigation of Medical Devices

• Even though Class A devices may not require clinical trials, following ISO 14155 for monitoring the safety and performance of medical devices post-market is beneficial.

ISO 19011:2018 - Guidelines for Auditing Management Systems

• This standard provides guidelines for auditing the processes and management systems that may be involved in post-market surveillance, helping ensure ongoing compliance.

📑 Summary of Standards for Class A Medical Device Registration under MDACS:

1. MDACS Guidelines: Primary regulatory framework for classification and registration.

2. ISO 13485 (Quality Management) - Recommended but not required.

3. ISO 14971 (Risk Management) - Recommended but not required.

4. ISO 10993 (Biological Safety) - Optional, mainly for devices with body contact.

5. IEC 60601-1 / IEC 61010-1 (Electrical Safety) - Relevant for electrical devices.

6. ISO 15223-1 & ISO 20417 (Labeling and Symbols) - Mandatory for proper labeling.

7. ISO 14155 & ISO 19011 (Post-Market Surveillance) - Optional but recommended for monitoring device safety.

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