[Contribution] Improvement of digital medical device approval and review system and strategic response to industry

Lawyer Seohyung Lee of Daeryun Medical Pharmaceutical Group
Focusing on the establishment and revision of 6 types of digital medical device guidelines by the Ministry of Food and Drug Safety

On May 7, the Ministry of Food and Drug Safety established and revised six types of guidelines related to digital medical devices. This enactment and revision is a measure to more specifically reorganize the regulatory system for the overall digital health technology, and will require a more strategic response not only from companies but also from stakeholders such as hospitals and research institutes.

The newly established and revised guidelines are as follows.

■ Enactment

- Digital medical device software approval and review guidelines

■ revision
① Guidelines for licensing and review of digital medical devices using artificial intelligence technology
② Medical device software approval and review guidelines
③ Permission and review guidelines for digital medical devices using virtual convergence technology
④ Digital therapeutic device approval and review guidelines
⑤ Guidelines for designing clinical trial methods for digital medical devices using artificial intelligence technology

These guidelines clearly divide review criteria according to technology type as follows.

1. Machine Learning-enabled Medical Devices (MLMD)

The Ministry of Food and Drug Safety determines whether software that uses machine learning technology is a digital medical device by focusing on 1) whether the software does not operate as intended and is likely to cause harm to patients, and 2) whether the software guarantees clinical judgment by medical personnel.

Specific permission and review requirements include △ characteristics of learning data such as information and expected update cycle △ accuracy of diagnosis using items such as sensitivity, specificity, and AUC △ clinical results based on independence and objectivity of test data sets, etc.

2. Digital medical devices based on virtual convergence technology

Meanwhile, in order for a device using VR, AR, or MR technology to be judged as a medical device, the purpose of use must be related to the diagnosis or treatment of a disease, and the composition and operating principle of the device must be consistent with that purpose. If there is a lack of data explaining the causal relationship for medical efficacy, such as improvement of patient symptoms, this may lead to a request for submission of supplementary data.

In addition, verification of safety, such as emergency stop devices, and verification of performance, such as accuracy, reaction speed, and image reproduction, are considered as major review items.

3. Embedded vs. standalone software

In the established 'Digital Medical Device Software Permission/Examination Guidelines', digital medical device software is divided into stand-alone and embedded software, software accessories or electronic interfaces, and application and document submission items are classified according to their characteristics. In the case of embedded types, it is necessary to prepare and submit data on medical device hardware in addition to performance or characteristics, purpose of use, method of use, etc. in accordance with the ‘Regulations on Digital Medical Product Permission, Certification, Reporting, Review and Evaluation, etc.’.

Meanwhile, in the case of digital therapeutic devices, they are independent digital medical device software, so they comply with the corresponding approval and review requirements. In addition, considering the characteristics of digital therapeutic devices, it must be possible to submit data considering additional matters such as the scientific (clinical) operating principle of the treatment mechanism, clinical trial results (real-world use evidence (RWE) obtained by analyzing real-world use data (RWD) when necessary after approval), and software verification and effectiveness.

4. Practical response: Regulation design must be carried out in parallel from the planning stage

According to the above guidelines, the importance of establishing regulatory strategies throughout the entire development cycle of digital medical devices is emphasized. Companies, hospitals, institutions, etc. must be able to strategically respond to the following issues starting from design.

- Whether our products using AI or virtual convergence technology meet the requirements for digital medical devices
- Setting the scope of review according to software classifications designated by the Ministry of Food and Drug Safety: Built-in, Standalone, and Other
- Composition of technical data and clinical data according to applicable guidelines
- Establish a follow-up response system in case of algorithm changes or updates

If this structural response is lacking, it may lead to delays in permits, repeated requests for supplementation, and sanctions related to labeling and advertising.

Daeryun Medical Pharmaceutical Group, a law firm, is a partner that goes beyond a technology-centered approach to comprehensively design regulatory interpretation and strategy establishment, providing effective advice throughout the entire process of digital medical device approval, review, and follow-up management.

The establishment and revision of the 2025 Ministry of Food and Drug Safety guidelines were carried out in the process of establishing regulations for the digital health industry. Technology alone can no longer guarantee market entry, and the ability to strategically prepare for and respond to regulations will determine industry competitiveness.

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[Contribution] Improvement of digital medical device approval and review system and strategic response by industry (go to)