The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document of a life cycle approach for software medical devices. The document provides additional clarification regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. The provisions of the guidance are non-binding, and should not be construed as legal advice.
According to the guidance, product registration application for medical devices submitted to HSA must be prepared in the format set out in the ASEAN Common Submission Dossier Template (CST) document and may be prepared from the International Medical Device Regulators Forum (IMDRF) Non-In Vitro Diagnostic Medical Device Market Authorization Table of Contents (nIVD MA ToC). The present guidance addresses the matters related to safety and performance, labeling, software verification and validation, risk management, and clinical evidence.
Table of Contents
Essential Principles for Safety and Performance of Medical Devices
Under the general rule, any medical devices should be created in a way ensuring they do not expose patients to additional risks and operate for the intended purpose. For this purpose, the Essential Principles for Safety and Performance checklist should be applied. A medical device should comply with the respective safety and performance requirements, while any non-compliance should be duly justified by the manufacturer. The authority additionally emphasizes that such an approach should be applied to all medical devices, including the ones with the lowest risk. In this regard, the document also refers to the Guidance on Essential Principles of Safety and Performance of Medical Devices, as well as the essential principles developed by the IMDRF.
To assist medical device manufacturers, the present guidance outlines the main design and manufacturing principles that could be applied in the case of software devices. All the principles are divided into two groups depending on the type of software in question. The first group includes software embedded in medical devices, and the second includes standalone software, standalone mobile applications, and web-based software.
Labeling Requirements
In terms of labeling the HSA applies the general approach according to which the concept of labeling covers not only the labels placed on the medical device itself but also other materials supplied with the device, including the instructions for use. As explained by the HSA, the labeling is intended to ensure identification of the device and its traceability, and also to provide important information to users (healthcare professionals and patients). The most important information was necessary for ensuring identification should be placed on the device itself, while additional safety-related information could be provided in the instructions for use and other documents accompanying the device.
In the case of software medical devices, specific aspects related to the supply of software should be considered. For instance, the software could be supplied without physical media. In such a case, standard labels could not be applied. According to the guidance, if the software is intended to be supplied in such a way, its manufacturer (developer) should provide a screenshot of the software graphical interface (e.g. splash screen) that displays the elements for identification, including the software version number. Additionally, if the software product in question is intended to be downloaded directly by its user, the manufacturer should also ensure the information duly communicated to the user contains the details on the download and installation procedure. Moreover, the authority states that even when such a form of delivery is used, the appropriate measures necessary to ensure its traceability should be implemented.
Software Versioning and Traceability
According to the guidance, software versioning plays an important role in ensuring traceability of software medical devices, as well as the effectiveness of field safety corrective actions that could be undertaken by a medical device manufacturer (software developer) in case of safety- or performance-related issues associated with the software. In this regard, the authority states that the information about the version of the software should be clearly stated either on the label (if applicable)or in the interface of the software. Furthermore, the software version should reflect all the changes the software was subject to.
Design Verification and Validation
As it is stated by the HSA, software medical devices should be designed to ensure accuracy, reliability, precision, safety, and performance, while fulfilling their intended use. According to the guidance, this should be supported by the respective evidence. Under the general rule, the aforementioned processes are intended for the following purposes:
- Software verification is intended to ensure the final product meets the initial specifications;
- Software validation is intended to ensure the product covers the respective needs.
According to the document, the appropriate report should be prepared, containing the results of both processes. In the course of validation and verification, special attention should be paid to any deviations identified. The medical device manufacturer (software developer) should analyze these deviations and assess additional risks associated thereto, as well as the impact they can cause to the safety and performance of the software medical device in general.
The authority additionally emphasizes that should the version of the software submitted for registration be different from the one subject to validation, it would be also necessary to provide compassion highlighting the differences between them.
Another important aspect addressed in the guidance is related to connections with other devices. If the software medical device is intended to interact with other medical devices when used for its intended purpose, the assessment to be carried out by its manufacturer should also cover the aspects related to such connections, while the assessment of the safety and performance of the device itself would not be sufficient.
Clinical Evaluation
The safety and effectiveness of medical devices are usually assessed during a clinical evaluation when the product is used for its intended purpose and in the intended use environment. In this regard, the authority states that clinical association refers to the extent to which the software’s output (concept, conclusion, measurements) is clinically accepted or well-founded (existence of an established scientific framework or body of evidence) that corresponds accurately in the real world to the healthcare situation and condition referred in the software’s defined intended purpose.
In summary, the present HSA guidance covers the most important principles to be considered by medical device manufacturers (software developers) in the context of pre-market product registration. The document describes in detail the types of assessment and evaluation to be undertaken before the software medical device would be made available for healthcare professionals and patients.
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