Popular Products a Notification Won't Cover — Low-Frequency Stimulators and Personal Warmers Need “Certification”

Key takeaway — A large share of the health-related devices commonly sold online are Class 2 medical devices under the MFDS product classification. The functions a low-frequency (EMS) massager claims map to the personal low-frequency stimulator (A83010.01), and an electric heating pad to the personal warmer (A83060.01) — both Class 2. Unlike a Class 1 notification, Class 2 is subject to “certification,” which involves a technical file review — so on top of the KRW 130,000 statutory fee, the review body's fee and testing costs come as separate at-cost expenses, product-specific standard testing and KGMP compliance recognition attach to the process, and the practical lead time is typically 3–4 months. Build your schedule on “a notification should do it” and the entire sourcing plan slips. Before signing a sourcing contract, confirm the product classification first.

Why a notification will not do — class determines the procedure

If part 1 of this series dealt with the boundary question — “is my product a medical device?” — the next gate is class. Medical devices are divided into Classes 1 through 4 according to intended use and the potential risk they pose to the human body (the MFDS notification “Regulation on Medical Device Items and Class-by-Item Designation”), and this class determines which procedure you follow.

Class	Procedure	Review
Class 1	Notification	No technical file review — the filing is checked and accepted
Class 2	Certification	Review of the technical file by a review body
Class 3·4	Approval	MFDS review of the technical file and, where required, clinical data

The problem is that the popular products online sellers handle often defy the intuition that “low risk must mean Class 1.” Devices that pass electric current through the body (low-frequency stimulation), apply heat (thermotherapy), or measure bodily states (temperature, blood pressure) are in large part assigned to Class 2. The full picture of procedures, timelines, and costs by class is laid out in the procedure overview by class.

Is the product you plan to sell really Class 2 — a cross-reference table of popular items

From the product classification in Annex 1 of the MFDS notification “Regulation on Medical Device Items and Class-by-Item Designation,” the items with the largest overlap with online selling are the following.

Classification no.	Item name	Class	Products that fall here
A83010.01	Personal low-frequency stimulator	Class 2	Low-frequency (EMS/TENS) massagers claiming “pain relief or improvement of muscle atrophy”
A83060.01	Personal warmer	Class 2	Electric heating pads and heated mats claiming “muscle pain relief” and the like
A83080.01	Personal combination stimulator (Class 2)	Class 2	Combinations of two or more functions, such as low-frequency plus heat
A82010.01	Medical vibrator	Class 2	Vibration, percussion, or compression stimulation devices for relieving muscle pain
A21010.03	Electronic thermometer	Class 2	Household electronic thermometers
A23010.04	Automatic electronic blood pressure monitor	Class 2	Home blood pressure monitors with automatic cuff inflation

Three things have to be read alongside this table.

First, the fork in the road is still the claims. Even for the same vibration device, the notification states in its definition of the medical vibrator that electric massagers manufactured simply to benefit general health are not included. In other words, the road splits: sell it as a consumer-product massager that makes no medical-device claims, or obtain Class 2 certification and say “pain relief.” That boundary question is covered in detail in part 1 of this series.

Second, combining functions can push the class up. The personal combination stimulator is Class 2 (A83080.01) when the highest class among its individual functions is Class 2, but becomes Class 3 (A83080.02) once a Class 3 function is mixed in. “Adding one more feature” can change the entire procedure.

Third, the table above is no substitute for checking the original text of the notification. Product classification can change as the notification is amended, and which item an actual product falls under is a judgment made by matching intended use and principle of operation. Before signing a sourcing contract, check the original classification text first.

Class 1 notification vs. Class 2 certification — what actually differs

The names sound close, but the procedures differ in kind. If a Class 1 notification is a matter of “assembling the paperwork, filing, and having it accepted,” Class 2 certification is a procedure for proving with test data and documents that the product is safe and performs.

	Class 1 notification	Class 2 certification
Nature of the procedure	No technical file review	Technical file reviewed by a review body (KTL, KTR, etc.)
Testing	Not required in principle	Product-specific standard testing: electrical and mechanical safety, EMC, performance, etc.
KGMP	Most items exempt (exceptions such as sterile products)	Compliance recognition required — running it in parallel with the technical file is the key to saving time
Statutory fee	KRW 85,000	KRW 130,000 + technical file review body's fee (separate, at cost)
Timeline	Statutory 5 days; typically 2–4 weeks in practice	Typically 3–4 months in practice

Look only at the difference in government fees (KRW 85,000 vs. KRW 130,000) and the burden seems small — but the real cost of Class 2 arises in testing, the review body's fee, and KGMP. All of these are at-cost amounts paid directly to testing and review organizations, so when comparing quotes, the first thing to check is whether agency fees and at-cost expenses are itemized separately. The step-by-step of a Class 1 notification is covered in the seller's guide to Class 1 notification, and the five stages of Class 2 certification with the variables that drive its timeline in the Class 2 medical device certification guide.

What sellers need to check

If you buy stock domestically or sell on consignment — check the supplier's certification number. The holder of an item certification is the manufacturer or importer, so a seller who buys an already-certified product in Korea and resells it does not obtain a new certification; what you verify instead is the supplier's certification number and whether you yourself need a sales business notification. And what to look for is not a “notification number” but the registration that matches the item — for Class 2, that means a certification.

If you import directly or manufacture your own — the entire certification procedure becomes your job. From the import business license (or manufacturing business license) through testing, the technical file, KGMP, and filing for certification, that schedule has to be built into your sourcing plan. In particular, how far the overseas manufacturer's existing test reports are accepted in Korea varies case by case, so screening the manufacturer's documentation first is the starting point for cutting duplicate testing costs.

Either way — advertise only within the certified scope. Even with certification in hand, labeling and advertising are permitted only within the certified intended use, and wording that goes beyond it circles back to the misleading-advertising problem. Frequently asked questions, including fees and timelines, are covered in the FAQ section of this guide.

What CLARE Partners does

CLARE Partners handles each stage of Class 2 certification as separately itemized services.

• Class 2 certification agency service — the full certification procedure including technical file drafting support, MFDS filing, and responses to review deficiencies, from ₩6.0M in agency fees (the KRW 130,000 statutory fee and the review body's fee are itemized separately)
• Test commissioning and management — from test item design through comparing and commissioning testing laboratories to managing the reports, from ₩2.0M (testing costs are paid to the laboratory at cost, separately)
• Import or manufacturing business license service — preparing and filing the license application, including review of facility and quality manager requirements, from ₩2.0M
• Sales (rental) business notification service — document preparation and filing, from ₩0.5M
• Free pre-review — send us your product information and we give a first response within 1 business day on the item, class, required procedures, and the state of your documentation

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

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The most expensive mistake in Class 2 is a schedule and budget built on “we thought it was Class 1.” Confirming the class is cheapest before the sourcing contract is signed. Send your product information and the wording you intend to use through a free pre-review, and we start by confirming which class the classification assigns, what testing is needed, and how long the overall schedule runs.

Sources: Annex 1 of the 「의료기기 품목 및 품목별 등급에 관한 규정」 (MFDS Notification No. 2026-18, effective March 9, 2026) — per the original text in the National Law Information Center. The approval–certification–notification distinction follows the Medical Devices Act (Act No. 21263, effective July 1, 2026), Article 6 (Manufacturing Business License, etc.) and Article 15 (Import Business License, etc.); fees follow Article 65 (Fees) and Annex 10 of the Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 2127, effective July 1, 2026). Product classification and fees may change as notifications and statutes are amended, and the item and class of an individual product may be judged differently depending on its intended use and principle of operation.