Software products have become almost ubiquitous in all kinds of medical practices and environments. As there are various types of software with different intended uses, it is easy to cause confusion and misunderstanding in the medical device registration process. Hence, TFDA has recently updated the guidance regarding the classification of medical-related software devices to provide clearer instructions during applications.

The content of the guidance is summarized as the followings:

  1. Terms and Definition

Medical-related software devices are:

  • • Software devices that are utilized to collect, store, analyze, display, or transfer data on human health status, physiological parameters, or any related medical records.
  • • Sites of application include medical institutions, hospitals, clinics, home care, or telemedicine service.

  1. Defining Software as Medical Device (SaMD)

Not all medical-related software devices will be regarded as SaMD, depending on the following points:

  • • Does the software meet the definition stated in Article 3 of the Medical Devices Act?
  • • Does the software belong to any of the scopes listed in Article 4 of the Regulations Governing the Classification of Medical Devices?
  • • Is the software able to perform or assist in disease diagnosis or treatment?
  • • The importance of the software in the field of disease treatment.
  • • The contribution and reference value of the software in the field of disease diagnosis.
  • • The potential hazard level of the software to human beings.
  1. Possible Forms of SaMD
  • • As one of the compositions or an accessory of a medical device.
  • • Stand-alone software
  • • Mobile application (App)
  • • Record media


Below are some examples of medical-related software devices:

  1. Medical-related Software Devices that are NOT Classified as SaMD
  • • Administration software that does not replace the diagnosis or decision of medical personnel.

E.g., Hospital Information Systems, Electronic Medical Records, Laboratory Information Systems, or Hospital Financial Systems.

  • • Software for medication records or dose calculation that does not directly provide medication guidance to patients.
  • • General wellness software.

E.g., Weight Management Software, Physical Fitness Software, Products Intended for Recreational Use, Relaxation or Stress Management Software, Mental Acuity Software, or Sleep Management Software.

*However, if the software is used to process or transmit data generated by other medical devices, it will be considered as SaMD.

  1. Medical-related Software Devices that are Classified as SaMD
  • • Software for processing medical images.
  • • Computer-assisted detection (CADe), computer-assisted diagnosis (CADx), or computer-aided triage software.
  • • Software for patient treatment planning.
  • • Software for monitoring patient physiological parameters.
  • • Software for telemedicine services.
  • • Software for analyzing multiple clinical biochemical indicators.



Guidance for the Classifications of Medical-related Software Devices