Update on Medical-Related Software Classification
The Taiwan Food and Drug Administration (TFDA) has recognized the necessity for updating the classification of medical software products due to technological advancements and the diverse applications of software in medical settings. This update is crucial as it affects the medical device registration process and aims to reduce the confusion surrounding various product classifications. Recently, the TFDA has released updated guidance to clarify the classification of medical-related software devices and streamline the application process.
Summary of Guidance
The content of the guidance is summarized as follows:
| Terms and Definitions | Medical-related software devices are: |
|---|---|
| Definitions | - Software devices that collect, store, analyze, display, or transfer data on human health status, physiological parameters, or any related medical records. |
| - Applicable in medical institutions, hospitals, clinics, home care, or telemedicine services. | |
| Defining Software as Medical Device (SaMD) | Not all medical-related software devices are regarded as SaMD. Classification depends on the following points: |
| - Does the software meet the definition stated in Article 3 and Article 4 of the Medical Devices ACT? | |
| - Does the software belong to any of the scopes outlined in Article 4 of the Regulations Governing the Classification of Medical Devices? | |
| - Is the software capable of assisting in the diagnosis or treatment of diseases? | |
| - The importance of the software in disease treatment. | |
| - The contribution and reference value of the software in disease diagnosis. | |
| - The potential hazard level of the software to human beings. | |
| Possible Forms of SaMD | - As a component or accessory of a medical device. |
- Stand-alone software
- Mobile applications (Apps)
- Record media | | Examples of Medical-Related Software Devices | Medical-related Software Devices that are NOT Classified as SaMD | Medical-related Software Devices that are Classified as SaMD | | --------------------------------------------- | --------------------------------------------------- | ---------------------------------------------- | | - Administrative software not replacing diagnosis or decisions of medical personnel. | - Software for processing medical images. | | (e.g. Hospital Information Systems, Electronic Medical Records) | - Computer-assisted detection, diagnosis, or triage software. | | - Software for medication records or dose calculation that doesn't provide direct guidance to patients. | - Software for patient treatment planning. | | - General wellness software. | - Software for monitoring patient physiological parameters. | | | - Software for telemedicine services. | | | - Software for analyzing clinical biochemical indicators. |
Reference
TFDA Guidance - https://www.fda.gov.tw/TC/siteListContent.aspx?sid=11652&id=41637