Digital Therapeutics Approval in Korea — A Name Absent from the Statute, Present in a Product Code

Key takeaway — The first fact a digital therapeutics company meets in Korea is this: the statute does not contain the name. Search the Digital Medical Products Act, its Decree and its Enforcement Rule and the term "digital therapeutics" does not appear. Where it sits in a normative document is one cell of the product code in Annex 3 of the classification and grading notification. That cell decides three things — the class, whether the route is approval, certification or notification, and whether clinical evaluation data can be waived. Set out from the text, current as of September 2026.

1. The map of the scheme

The Digital Medical Products Act, enacted on 23 January 2024 and in force from 24 January 2025, added a layer. It adds rather than replaces.

• Article 5 (relationship with other statutes) — for digital medical devices, the Medical Devices Act and the In Vitro Diagnostic Medical Devices Act apply mutatis mutandis except as provided in this Act
• Article 8(1) — a manufacturing licence under this Act is deemed a manufacturing licence under Article 6(1) of the Medical Devices Act, limited to digital medical devices

The Act divides products into three (Article 2(1)).

Category	Substance of the definition
Digital medical device	A medical device (including in vitro diagnostic devices) to which digital technology is applied, or such a device combined with a digital medical or health support device
Digital convergence drug	A drug under the Pharmaceutical Affairs Act combined with a digital medical device. Excluded where the principal function is that of a digital medical device
Digital medical or health support device	Not a digital medical device; a product for monitoring or measuring biosignals or recording and analysing lifestyle for medical support or health maintenance, designated by the MFDS Minister

"Digital technology" is defined in Article 2 of the Enforcement Rule — intelligent information technology, intelligent robot technology, information and communications technology, virtual convergence technology, and other advanced technologies published by the Minister.

The first fork follows. Software as a medical device without applied digital technology remains under the Medical Devices Act; only where digital technology is applied does the Digital Medical Products Act sit on top. The judgment covered in the SaMD approval guide comes first.

2. Where "digital therapeutics" lives — the product code

Annex 3 of the Regulation on Classification and Grading of Digital Medical Products builds a seven-character product code.

2 characters for principal intended use + 3 for the type of digital technology + 2 for the form

The principal intended use runs from A to I — A testing, B diagnosis, C treatment, D clinical management guidance, E disability assistance or mitigation, F information provision and management, G drug assistance, H other purposes, I convergence products.

The second character under C (treatment) divides as follows.

Code	Detailed intended use
C1	Surgery or procedure (support)
C2	Treatment planning and simulation
C3	Digital therapeutics
C4	Other

This is the only place in the current framework where "digital therapeutics" appears as normative text. It is not a separate legal product category but a coordinate in the product code.

The digital technology characters divide into A standalone software technology, B artificial intelligence technology, C intelligent robot technology, D high-performance computing technology and E virtual and convergence technology.

A definition does exist elsewhere. The MFDS civil-petitioner guideline Guidelines on Approval and Review of Digital Therapeutics (Guideline No. 1045-01, 27 August 2020) describes digital therapeutics as software as a medical device that delivers evidence-based therapeutic intervention to patients in order to prevent, manage or treat a medical disorder or disease. That guideline was, however, written on the basis of the Medical Devices Act before the Digital Medical Products Act, and states that it carries no external legal effect.

3. What the coordinate decides, first — the class

Annex 4 of the classification notification grades standalone software on a two-axis matrix.

Medical situation \ Effect on healthcare	Treatment, rehabilitation, testing, diagnosis, drug assistance	Clinical management guidance	Information provision, management, other
Critical or life-threatening (death within 24 hours)	Class 4	Class 3	Class 2
Serious (severe disease)	Class 3	Class 2	Class 1
Not serious	Class 2	Class 1	Class 1

An adjustment follows for the harm arising from degraded performance or malfunction — +1 where death is possible, −1 where there is no harm. Anything above Class 4 stays at Class 4, no downgrade is made from Class 2 to Class 1, and the adjustment does not apply where the assessment already reached Class 1.

Reading it is simple. Treatment is the leftmost column. For the same condition, information-provision software may be Class 1 or 2 while software claiming treatment goes to Class 3 or 4.

Where a class cannot be assigned, the device is left ungraded and a grading request may follow approval (Annex 4(c)). Article 7(3) of the same notification provides that the class is finally determined when approval or certification is granted or the notification accepted.

4. What the coordinate decides, second — the approval track

Article 6 of the Enforcement Rule divides the tracks.

Track	Scope
Certification by product group	Class 2 devices among published items
Notification by product group	Class 1 devices among published items
Product-by-product manufacturing approval	Class 3 and 4, ungraded devices, and Class 2 devices filed jointly with a new health technology assessment
Product-by-product certification	Class 2
Product-by-product notification	Class 1

Read together with the matrix in section 3, the conclusion follows: software claiming a therapeutic purpose is mostly on the product-by-product manufacturing approval track.

The procedural deadlines are in the text — a manufacturing licence is notified within 25 days of application (Article 8(8)), and if no notice issues within that period the licence is deemed granted (Article 8(9)). A change to a manufacturing licence is within 15 days (Article 11).

5. What the coordinate decides, third — the clinical data waiver

This is the most practical part of the guide.

Article 24(1) of the Regulation on Approval, Certification, Notification, Review and Evaluation of Digital Medical Products (the current version as checked in September 2026 is Notification No. 2026-54 of 27 July 2026) lists eight submissions for standalone software — intended use and principle of action, domestic and overseas status and development history, software verification and validation, clinical evaluation data, protection against electronic intrusion, usability, professional-use material, and, where artificial intelligence is applied, a change management plan.

Waivers sit in Article 25.

Basis	What is waived	Condition
(1)1	Software verification and validation, security, usability	An excellence management system certificate holder obtaining approval or certification for ungraded or Class 2 standalone software
(1)2	Material already reviewed	Submission of a prior review result notice
(1)3	Clinical evaluation data	Submission of a performance evaluation result plus the company's own consistency assessment
(1)4	Clinical evaluation data	The intended use falls within Annex 3 and no clinical effectiveness is claimed
(4)	Everything but the added matter	Where digital technology is applied to an already approved device and a fresh approval is sought

The treatment entries in Annex 3 are only position provision and treatment planning, and even those exclude products applying intelligent robot technology.

This is where the position of digital therapeutics becomes clear. Every waiver under (1)4 is conditioned on not claiming clinical effectiveness, and claiming therapeutic effectiveness is the definition of digital therapeutics. That route therefore does not open.

Four paths remain.

• Prior review (Act Article 39) — review of approval and clinical trial material may be requested in advance, and the Minister shall take the result into account
• Deemed submission (Notification Article 25(2)) — using an already approved standalone software function without program change, demonstrating that the hardware is equivalent to an approved device, or demonstrating clinical safety and effectiveness through re-evaluation
• Adding digital technology only (Article 25(4)) — where digital technology is applied to an already approved device, only the material for the added matter need be submitted
• Real-world performance evaluation (Act Article 15) — the device may be provided to healthcare professionals and institutions and usage records requested, and that material may be used in the approval or a change approval

Waivers of the clinical trial plan approval itself are listed in Article 14(3) of the Enforcement Rule in six cases. Three arise often in practice — a data-based clinical trial using existing data without direct use on subjects, a trial for real-world performance evaluation within the scope of a change management plan, and a trial conducted by an excellence management system certificate holder on Class 1 or 2 standalone software.

6. Provisions that attach only to standalone software

The statutory term corresponding to the old SaMD is "standalone digital medical device software" in Article 2(7)(b). Provisions attach to it alone.

• Articles 24 and 25, quality management conformity determination — the determination must be obtained, and it is valid for three years, extendable within three years on a satisfactory periodic inspection
• Article 27, sales exception — where the company's own manufactured or imported standalone software is sold as a subscription or provision of an information and communications service, or by electronic installation, a distributor notification may be dispensed with
• Article 28, partial disapplication of the Medical Devices Act — several Medical Devices Act provisions do not apply to standalone software, unless there is a serious risk to public health
• Article 14, security — the Minister establishes a security guideline, and manufacturers, importers and maintenance contractors must observe it
• Article 22, labelling — the approval number and manufacturing number and date are recorded together with version information
• Article 26 — maintenance and management work may be outsourced to a third party

7. Approval is not the end

For a product claiming treatment there is one more door after approval. For a hospital to charge for the act of using the device, that act must already be a listed item; if it is not, it goes through new health technology assessment at the Ministry of Health and Welfare. That Article 6 of the Enforcement Rule separately names Class 2 devices filed jointly with a new health technology assessment as a product-by-product approval case reflects how often the two procedures move together. See the new health technology assessment guide.

Common mistakes

• Reading only the 2020 guideline and skipping the Digital Medical Products Act framework
• Treating digital therapeutics as a statutory product category and expecting a dedicated track — the class sets the track
• Claiming clinical effectiveness while expecting the Annex 3 waiver
• Applying artificial intelligence without preparing the change management plan (Enforcement Rule Article 7(2), Notification Article 24(1)8)
• Extending the subscription-sales notification exception to every form of sale
• Leaving the three-year validity of the quality management conformity determination out of the register

Pre-application checklist

• Establish whether the product applies digital technology under Enforcement Rule Article 2 (if not, the Medical Devices Act track applies)
• Identify the principal intended use coordinate in the Annex 3 product code (C3, or B, or F)
• Estimate the class from the Annex 4 matrix and consider the +1 / −1 adjustment
• Fix the approval, certification or notification track under Enforcement Rule Article 6
• Settle in writing whether clinical effectiveness is claimed — the waiver routes turn on this
• If artificial intelligence is applied, add the change management plan to the submission list
• Decide whether and when to use prior review (Act Article 39)
• Decide before filing whether to file jointly with a new health technology assessment

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Digital therapeutics sit inside a scheme that manages products by coordinate rather than by name. Once the coordinate is fixed, the class, the track and the submission scope follow. Where your product sits and which relief routes are open is what we check first in a free preliminary review.