Professional-use software can include a patient application
South Korea’s Ministry of Food and Drug Safety (MFDS) issued its Guideline for Approval and Review of Professional-Use Digital Medical Device Software, an English translation of the Korean title, on September 30, 2026. The registered identifier is 안내서-1528-01.
The guidance addresses manufacturing and import approval or certification for software whose intended purpose and performance require professional involvement. It includes both standalone and embedded software designed for patient use following a healthcare professional’s diagnosis, direction or supervision. A clinician dashboard and a patient application may be separate software products or independent modules within one package.
This is a newly established applicant guidance document. It explicitly states that it has no external legal effect. Its publication and approval date is September 30; it specifies no separate mandatory effective date or transition period. Applicable underlying legislation and regulations still need to be assessed for each product.
The submission should explain both sides of supervised use
The guidance calls for application information to distinguish professional supervision software from patient software. Precautions should cover shared matters, such as indications, contraindications, adverse effects, intended patients, use environment, and software update and technical support policies, alongside information specific to each user.
Professional information should explain the clinical meaning of outputs and the professional’s intervention, including monitoring, feedback and escalation. Patient information should explain supervised use, the prescribed usage pattern, risks of unsupervised use and expected clinical effects in plain, intuitive language. The guidance uses comprehension by a person aged 13 or above as a readability reference, with attention to the intended patients’ literacy and cognitive abilities; this is not a minimum patient age.
For standalone digital medical device software, supporting material should demonstrate why professional diagnosis, direction or supervision is necessary for safe and effective patient use. The guidance lists clinical evaluations including adverse-event information, real-world evidence, literature and use cases for equivalent products as examples. It does not impose a blanket new clinical-trial requirement. Instructions for use should be assessed during usability evaluation.
An annexed checklist maps applicable disclosures to application content and the supporting instructions’ document numbers and page locations. Where an item does not apply, the guidance calls for an objective explanation.
What Korean-market teams can check first
- Confirm whether safe patient use depends on professional involvement, considering intended purpose, users, environment, operation and performance.
- Align the clinician and patient modules, warnings and instructions with the actual supervision workflow.
- Where applicable, map supervision-related evidence and instructions to the annexed checklist, including justified nonapplicable items.
This specific guidance introduces no new risk-classification scheme, AI validation framework, cybersecurity standard or formal software change-approval procedure. Its reference to update policies and support concerns information provided to users. Teams should assess any separate requirements for those subjects under the applicable Korean framework.
For an existing Korean project, a focused review of the supervision workflow, supporting evidence and instructions can identify where the submission needs clearer documentation.
Sources
- Primary official source전문가용 디지털의료기기소프트웨어 허가·심사 가이드라인 (opens in a new tab)Ministry of Food and Drug Safety
- Supporting source전문가용 디지털의료기기소프트웨어 허가·심사 가이드라인(민원인 안내서) — PDF (opens in a new tab)Ministry of Food and Drug Safety