In April of 2015, NMPA released the Guidance of Software for Medical Device Registration. In this June, NMPA released the Draft Revision of Guidance of Software for Medical Device Registration(hereafter called “Revision”). This Revision applies to the registration of medical device software, including Class II and Class III stand-alone software, medical devices containing software components. For example, the manufacturer-developed software and off-the-shelf software. Meanwhile, this Revision could be as a reference for verification of medical device software and quality management software systems.
In this article, we'll focus on the differences in scope of application, technical considerations, and registration requirements in the two editions of the guidance.
- 1. The Revision adds scope of application and technical considerations:
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First Edition |
Second Edition |
Difference |
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Scope |
The guidance applies to the registration of medical device software, including Class II and Class III medical device product, and applicable software development methods include self-development, partial use of off-the-shelf software and full use of off-the-shelf software.
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The guidance applies to the registration of medical device software, including Class II and Class III independent software and medical devices containing software components, and to the registration of self-research software and off-the-shelf software, also as a reference for verification of medical device software and quality management software systems. |
The new guidance defines the classification of medical device software while expanding its use. |
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Cybersecurity |
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Medical device cybersecurity needs to consider the network security and data security of medical device from the perspective of information security. Medical device software should consider network security issues if it has the function of electronic data exchange, remote control or user access control.
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New |
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Cloud computing
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Cloud computing can be considered as off-the-shelf software, cloud service providers as vendors, so business enterprises can consider the requirements analysis of cloud computing , risk management, verification and validation, maintenance plans and other activities, taking into account off-the-shelf software and vendor-related requirements.
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New |
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Mobile computing
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If the medical device software is applied in a mobile computing terminal for personal use, including medical computing terminals and general computing terminals, it belongs to a mobile medical device, and the technical characteristics and risks of mobile computing terminals should be considered comprehensively, and the specific requirements should be detailed in the relevant guidelines for mobile medical devices.
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New |
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Artificial Intelligence (AI)/Machine Learning (ML) |
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If it uses AI/ ML algorithm, medical device software belongs to the artificial intelligence medical device. And it should consider the technical characteristics of AI/ ML algorithm and its risks, the specific requirements are detailed in the guidance of artificial intelligence medical devices. |
New |
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Human factor in designing |
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Medical device software should strengthen human factor in designing of user interface, lowering the risk of user misuse to an acceptable level. Human factor in designing of software user interface requirements and basic elements of the medical device are detailed in the guidance.
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New |
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Interoperability |
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Interoperability refers to the ability of medical device and other medical device or non-medical device to exchange and use information through electronic interfaces. The electronic interface contains hardware interface and software interface, information including but not limited to medical images, physiological parameter data, gene sequencing data and control instructions.
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New |
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Expiration date
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The duration of the use of independent software is determined by commercial factors. Software components are used for the same period as their medical devices and do not need to be represented separately. Dedicated independent software is regarded as the same duration requirements as independent software, reflected in the medical device life study materials.
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New |
- 2. Comparison of registration requirement of the two versions of the Guidance
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First Edition |
Second Edition |
Difference |
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Product registration |
1, Product name and structure composition; 2, Software research materials; 3, Software version; 4, Product technical requirements; 5, Clinical evaluation data; 6, Off-the-shelf software (if any); 7, Specification. |
1, Information in registration certificate; 2, Software research materials; 3, Product technical requirements; 4, Specification. |
The new version does not require additional clinical evaluation data. The new version must be clear in the specification about software functions and interface details. |
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Change Application |
1, Alteration situation description; 2, Software research materials; 3, Product technical requirements; 4, Off-the-shelf software (if any); 5, Specification (if any). |
1, Software research materials; 2, Product technical requirements; 3, Specification. |
Software is divided into refined software updates, adaptive software updates, correction software updates and non-updates, which must be submitted related information. |
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Renewal Application |
1、Product statement without alteration； 2、Product analysis report (if any); 3、Special circumstances. |
1, No need to submit software-related research materials; 2、Product technical requirements. |
Registrants don’t need to submit software research materials and product non-change statements. Product technical requirements need to be submitted. |
| RECOMMEND READING |
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- China Registration Introduction - NMPA Published Update Guideline of Adverse Event Monitoring for Medical Device
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References:
- Guidance of Software for Medical Device Registration
- Draft Revision of Guidance of Software for Medical Device Registration