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In scope · product code · class
For a medical device or IVD with digital technology applied — standalone software, AI, a digital therapeutic — the manufacturer builds the 7-digit product code and sets the class itself, under 「디지털의료제품 분류 및 등급 지정 등에 관한 규정」. This tool reproduces the criteria from the annexes and the MFDS guidance and walks you through it in order: in scope → product code → class.
1Is it a digital medical device?
The questions follow Article 5 of the rule and section Ⅲ of the guidance, in that order. The source text sits under each verdict.
Base product type
Digital technology applied (Annex 1 — select all that apply)
Where the digital technology sits (Article 5(2) — select all that apply)
Intended use (Digital Medical Products Act, Art. 2(2))
Source text — Article 5 of the rule and section Ⅲ of the guidance
Why software items disappeared from the item table — Addendum Article 5
2Build the product code (Annex 3)
7 characters = primary intended use (2) + digital technology type (3) + base type (1) + form (1). Technology, base type and form are filled in from your answers in ①.
In reverse — read a product code
Annex 3 text — rules for building the code
3Set the class (Annex 4)
For software embedded in hardware, take the higher of the hardware class and the class of each embedded software function; for standalone software, the highest class among its software functions. A software function's class comes from ① the healthcare situation × ② the significance of the information, then ±1 for ③ the level of harm (no adjustment at class 1, no move from 2 to 1, 4 at most).
Device hardware — find the class by item code or item name (device and IVD item tables)
Digital medical device software functions (one per function)
Compared with international classification (reference) REGNA editorial
The numbers in the Annex 4 class table (4·3·2 / 3·2·1 / 2·1·1) are laid out the same way as categories IV, III, II and I in IMDRF's “SaMD: Possible Framework for Risk Categorization” (2014). EU MDR Annex VIII Rule 11 and the FDA use different schemes, so the same product can land in a different class; the mapping below is our editorial reading. The actual class must be determined separately under each regulator's own rules.
Definitions and examples (guidance section Ⅴ, original)
4Digital medical device GMP type groups (Annex 5 of 「디지털의료기기 제조 및 품질관리 기준」)
Digital medical device GMP runs on type groups rather than product groups. Software is split by whether it carries an AI/ML function; hardware is split into instruments, appliances, supplies, dental materials, IVD instruments and IVD reagents.
5Borderline cases
The three cases section Ⅵ of the MFDS guidance addresses directly (original text), and the items that sit on the borderline in the device and IVD item tablesREGNA editorial
- Combining already-approved standalone software with hardware or other software “physically” (the program changes) means a new approval as a single digital medical device, and clinical data is required; connecting them only “functionally” (no change to the program) means a supply contract and the approval numbers are enough, and clinical data is waivedGuidance Ⅵ-2. Note that separately approved products a user runs one after another in a hospital (an X-ray unit and PACS with image analysis software, say) are not a combination.
- Software dedicated to an IVD reagent — if it simply implements a formula already reviewed when the reagent was approved, or a well-known simple calculation (a general-purpose calculator), it is not a digital medical device; if AI is applied, or the formula was not part of the reagent's approval, it is a separate digital medical deviceGuidance Ⅵ-3. Where the 6th character is B or C, read the class criteria in Article 2(2) of the Enforcement Rule of the In Vitro Diagnostic Medical Devices Act alongside.
- Software that only transmits, stores, converts the format of or displays laboratory or device data to support a healthcare professional's work may fall outside approval and notificationEnforcement Rule of the Digital Medical Products Act, Article 11(6) (see the information-provision item in section Ⅴ of the guidance). Medical images are not within that exclusion.
- Where an AI software function is an “option” on the hardware, you may either approve only the equipped model as a digital medical device, or approve it together with the unequipped model as one productGuidance Ⅵ-1. Either way, if they operate as a single system it is one digital medical device, whether the software is general-purpose or dedicated.
- Where the class cannot be set under Annex 4, approve the product as “class not assigned” and then ask MFDS to assign oneAnnex 4, 2.c. Do not force it into a class that does not fit; the unassigned route is the correct one.
- X-ray and imaging equipment with “digital” in the nameA digital detector is hardware only, not a technology in Annex 1, so it is not a digital medical device. It qualifies only when image analysis or reading-support software (standalone or AI) is attached and bears on the intended use.
6Borderline with IVDs
Three things people most often get wrong about IVD items (codes I–O), answered from the notice.
Does 「의료기기 기준규격」 also apply to IVDs?
Test standards for IVD instruments — what if there is no Korean standard?
When it counts as a self-test IVD
IVD GMP product groups
7If you are not sure — MFDS pre-review and scope review
A scope review that asks only whether something is a digital medical device (Article 8) is filed with proof that the product is a medical device or IVD, the Annex 2 determination and its basis, and data on shape, structure, performance, intended use and method of use. You are notified of the result within 10 days.