Is My Product a Medical Device? — How to Find the Product Classification and Class

Key takeaway — Whether a product is a medical device is judged not by its material or performance but by the intended use it claims. Claim any of the four purposes set out in Article 2(1) of the Medical Devices Act (disease / injury and disability / structure and function / conception control) and a medical-device issue arises. If the definition applies, the next step is to find the product and its class in Annex 1 of the MFDS (Ministry of Food and Drug Safety) notification, the Regulation on Medical Device Items and Their Classes (No. 2026-18). A classification number pairs an alphabetic category with digits, as in “A26080.01”, and the class (1–4) determines the procedure — notification, certification, or approval — and with it the timeline and cost. When it is unclear, the pre-review mechanism under Article 11 of the Act lets you confirm officially with the MFDS.

What is a medical device — the four subparagraphs of the Article 2 definition

The starting point is always Article 2(1) of the Medical Devices Act.

In this Act, “medical device” means an instrument, machine, apparatus, material, software, or similar product used on humans or animals, alone or in combination, that falls under any of the following subparagraphs. Excluded are drugs and quasi-drugs under the Pharmaceutical Affairs Act, and prosthetic limbs and orthoses among the assistive devices for persons with disabilities under Article 65 of the Act on Welfare of Persons with Disabilities. — Article 2(1), Medical Devices Act

The word practitioners need to hold on to in that definition is “purpose.” Every subparagraph is built the same way: “a product used for the purpose of…”

Subparagraph	Definition (Article 2(1))	Products that claim this purpose
1	Diagnosing, treating, alleviating, caring for, or preventing disease	Devices marketed for “pain treatment” or “disease prevention”
2	Diagnosing, treating, alleviating, or correcting an injury or disability	“Forward-head posture correction” or “rehabilitation support” bands and braces
3	Examining, replacing, or modifying a structure or function	“Blood circulation improvement” devices; body-composition and ECG monitors
4	Controlling conception	Devices intended for contraception

Two implications follow. First, software can be a medical device. The definition names “software” explicitly, so an app or analysis program with a diagnostic or therapeutic purpose goes through the same test. Second, the same object changes character depending on what it claims. Claim none of the four purposes and the product generally stays in consumer-product territory; the moment one is claimed, a medical-device issue arises (although a product whose structure and form make its medical use obvious can be judged a medical device regardless of the claims). What goes wrong when a non-medical-device product advertises like one is covered in Part 1 of this series — the phrase “medical device” is not free for any online seller to use.

Where to find the product classification — searching Annex 1 of the notification

If the definition applies, the next question is “so which item is my product, and what class?” The legal basis sits in three layers: Article 3 of the Medical Devices Act obliges the MFDS Commissioner to classify and designate devices by class; Article 2 of the Enforcement Rule sets the criteria and procedure through its annex; and the classification number, product name, class, and item definition for every single item are carried in Annex 1 of the MFDS notification, the Regulation on Medical Device Items and Their Classes (MFDS Notification No. 2026-18, effective March 9, 2026).

There are three search routes.

Route ① — Read Annex 1 directly. Search the notification by name at the National Law Information Center and open Annex 1. Its strength is that it is the original source; the weakness is that finding your product in that vast item list takes a feel for which major category and product group to look in.

Route ② — Reverse-trace registered equivalents. In the “product approval (notification) details” search on the MFDS electronic filing portal (emedi.mfds.go.kr), search by the name or company of a competing or similar product to see the classification number, product name, and class under which it is registered. In practice this is the fastest route — the classification of a product already on the market is the strongest candidate for yours.

Route ③ — Interactive search. The same portal’s “interactive medical device search service” narrows candidate items through a question-and-answer flow about the product’s characteristics. It is useful for a first pass at the candidates, and it is safest to cross-check the results against Routes ① and ②.

One caution. A classification found by searching is a “strong candidate,” not a final determination. Even within the same product family, the item can turn on how the intended use and principle of operation are described, and the final call is made in the MFDS review.

How to read the classification number and class

Find your item in Annex 1 and you get a classification number + product name, like “A26080.01 heart rate meter”, with the class and the item definition (intended use) listed alongside. Read the number in three parts.

• One letter — the major category. Examples confirmed in the notification and related notifications: A (instruments and machines — heart rate meter, A26080.01), B (medical supplies — artificial eye, B03400), C (dental materials — dental implant guide, C21040.01), and E (software — cardiovascular care software product group, E01000). D (in vitro diagnostic reagents) was split off in 2020 into a separate notification regime, the Regulation on In Vitro Diagnostic Medical Device Items and Their Classes.
• Five digits — product group and product; the leading digits mark the larger grouping.
• Two digits after the decimal point — the individual item, distinguishing sub-items within the same product group.

And the class (1–4) attached to each item is what matters most in practice, because the procedure gets heavier as risk rises from Class 1 to Class 4. The class is effectively the table of procedure, timeline, and cost.

Class	Procedure	Statutory fee (electronic filing)	Typical timeline
Class 1	Notification (no review)	KRW 85,000	2–4 weeks
Class 2	Certification (technical file review)	KRW 130,000, plus the review body’s separate fee	3–4 months
Class 3	Approval	KRW 719,000 (technical file review included)	6–8 months
Class 4	Approval	KRW 719,000; KRW 1,495,000 when clinical data review is included	1 year or more when clinical data are required

These are the statutory government fees under Annex 10 of the Enforcement Rule of the Medical Devices Act (electronic filing basis), separate from any agency fee if you outsource the work. Amounts may change as legislation is amended. The full picture of each class’s procedure and what to prepare at each step is laid out in the class-by-class procedure overview.

The line between consumer products and medical devices — how borderline cases split

For borderline cases too, the axis of judgment is intended use. The MFDS publishes guidance on distinguishing medical devices from personal wellness products, and the skeleton is two questions — is the intended use medical, and is the risk high?

The example still visible in the regulation is the heart rate meter. The same heart-rate measurement function is wellness territory when claimed for sports and leisure, and is managed as the heart rate meter item (A26080) in Annex 1 when claimed for medical use. When the notification was amended in 2014, its addendum required a change approval before a sports-and-leisure heart rate or pulse meter could switch its intended use to medical (Addendum to Notification No. 2014-110). It shows that the claims, not the machine, draw the line.

The product families where boundary issues most often arise look roughly like this.

Product family	Consumer-product-side claims	Medical-device-side claims
Massage guns and massagers	Fatigue relief, relaxation	Pain treatment, muscle function recovery
LED masks	Skin beautification	Treatment of acne or skin disease
Posture bands	Support for posture habits	Body-shape or forward-head correction
Heart-rate and temperature wearables	Sports and leisure measurement	Disease diagnosis, medical-use measurement

Mind the direction. This table does not mean “switch to the left-hand wording and you are safe.” If the listing as a whole reads as claiming medical efficacy, swapping words leaves the issue alive (the misleading-advertising problem covered in Part 1); conversely, if the medical-side claims are the heart of your business, the straight path is to confirm the item and class and take the registration track.

Routes for checking your judgment in advance

Once your own assessment is done, verification comes in three stages.

Stage 1 — Cross-check on your own. Compare Annex 1 and registered equivalents through Routes ① to ③ above. No cost arises up to this point.

Stage 2 — Official confirmation from the MFDS. Article 11 of the Medical Devices Act lets a prospective applicant for manufacturing approval, certification, or notification request a review from the MFDS in advance on the materials the filing requires, and obliges the MFDS to confirm and notify the applicant of the result. Notably, Article 11 as amended on June 9, 2026 (effective December 10, 2026) explicitly lists “whether a product is a medical device under Article 2(1) and classification under Article 3(1)” among the matters for pre-review. The very questions this guide covers — is it a medical device, and what class — can now be asked through an official procedure.

Stage 3 — Expert review. Put the claims you intend to make and the product materials on the table together, and look at class, procedure, and expected cost in one pass. The points where judgments diverge — a measurement function or not, sterile or not, software included or not — change the class, and the class changes the budget, so this review is worth the most at the sourcing and planning stage.

What CLARE Partners does

CLARE Partners covers this verification process from start to finish.

• Free pre-review — send the product information and the claims you intend to make, and we give a first response within one business day on medical-device status, class, and the required procedure
• Class 1 notification, handled for you — from document preparation to filing, agency fee from ₩2.0M
• Class 2 certification, handled for you — technical file drafting support, MFDS filing, and deficiency responses included, agency fee from ₩6.0M
• Class 3 approval from ₩9.0M · Class 4 approval from ₩15.0M (statutory government fees itemized separately in the quote)

The full itemized agency fee schedule and how quotes are structured are on the regulatory consulting services page.

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Confirming the product classification and class is the first button of the registration process — and the point where budget and schedule get fixed. The cheapest time to check is when you are still deciding on the product, not after the listing is built and the inventory has landed. Send your product materials through a free pre-review and we will start by confirming medical-device status, class, and the required procedure.

Legal basis: Medical Devices Act (Act No. 21263, effective July 1, 2026) Article 2 (Definitions) · Article 3 (Classification and Designation) · Article 11 (Pre-review of Manufacturing Approval, Notification, etc.) (the provisions amended June 9, 2026 take effect December 10, 2026) · Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 2127, effective July 1, 2026), Article 2 and Annex 10 · Regulation on Medical Device Items and Their Classes (MFDS Notification No. 2026-18, effective March 9, 2026) — based on the original texts at the National Law Information Center; the content may change as legislation is amended.