Thermometers Are Medical Devices — Contact and Non-Contact Alike, and Unlicensed Sellers Have Been Caught

Key takeaway — Thermometers are medical devices whether they're contact or non-contact — and both are Class 2. Contact type is "personal electronic thermometer" (A21010.03); non-contact splits by application site into "infrared thermometer, ear" (A21010.04) and "infrared thermometer, skin" (A21010.05). And this isn't just a paper requirement — in December 2024, a real enforcement case was reported: a company manufactured and sold over a thousand non-contact infrared thermometers assembled from imported sub-assemblies, without a manufacturing license. Compiled as of September 2026.

Why the confusion — "thermometer" and "temperature sensor" are different claims

Industrial and food-service infrared thermometers look similar to medical non-contact thermometers. Both point a beam at a forehead or object and display a number.

But what determines regulatory status isn't the shape — it's the claimed intended use. Claim "measures body temperature" and it's a medical device. Claim only "measures surface temperature of an object" and it's a general consumer product.

The problem is that this line blurs during sale — products built for industrial use get advertised for body-temperature measurement, or products built as thermometers get sold without anyone checking whether they're certified.

Contact type — the electronic thermometer is Class 2

The contact-type electronic thermometer commonly used at home is classified under the "Regulation on Medical Device Items and Class-by-Item Designation" as personal electronic thermometer (A21010.03), Class 2.

Being Class 2 means it requires certification, not notification. It must go through review by a technical-document review agency, and testing fees (actual costs at the laboratory) plus the technical document review fee of KRW 561,000 (the statutory amount in Annex 10) are added separately. The overall Class 2 procedure is covered in the Class 2 Certification Cost Guide.

Non-contact (infrared) — the same Class 2 as contact type

Non-contact thermometers are also managed as medical devices, and at the same Class 2 as the contact type. Appendix 1 of the regulation splits them by where they're applied — infrared thermometer, ear (A21010.04) and infrared thermometer, skin (A21010.05).

In a September 2020 announcement, MFDS also stated that anyone measuring and recording individual body temperature should use an MFDS-certified thermometer, without distinguishing contact from non-contact — consistent with Appendix 1's classification.

Contact or non-contact, both require certification, not notification, since both are Class 2. The item name differs by application site, though, so file under the name matching ear or skin use.

A real enforcement case — December 2024

This isn't hypothetical. It actually happened.

According to a December 2024 report, a company manufactured over a thousand "non-contact infrared thermometers" (model OC365-T100) by importing sub-assemblies from China and assembling them domestically — without a medical device manufacturing license. It sold roughly 900 of them online and offline, from November 2020 through September 2022.

MFDS noted that the product, lacking medical device approval, could not guarantee accurate temperature measurement, and advised consumers to stop using it.

Assembling sub-assemblies is manufacturing, too

This is exactly the point where the case above went wrong. Importing a finished product as-is and importing sub-assemblies to assemble domestically are different requirements.

Importing a finished product falls under import business, but assembling and completing sub-assemblies domestically is treated as manufacturing a medical device at a domestic site — which requires a manufacturing license. Treating the two as the same and preparing accordingly means the license itself ends up missing from the process. How manufacturing and import licenses differ is covered in the Manufacturing License Guide.

What sellers should check

□ Confirm the "medical device" label and a certification number–model name appear on the product listing and packaging

□ Cross-check the certification information for that model at the medical device e-portal (emed.mfds.go.kr)

□ If you're importing sub-assemblies to assemble domestically, confirm manufacturing license status first

□ Don't advertise thermal-imaging cameras or facial-recognition devices as thermometers — uncertified equipment isn't recognized for personal temperature measurement

□ Don't claim body-temperature measurement for infrared thermometers built for industrial or food-service use

Common mistakes

• Advertising an industrial infrared thermometer for body-temperature measurement
• Assembling imported sub-assemblies without a manufacturing license
• Selling thermal-imaging or facial-recognition equipment marketed as a thermometer
• Filing an infrared thermometer without specifying ear (A21010.04) vs. skin (A21010.05) application
• Reselling sourced products with no certification number shown at all

Before you proceed

• Confirm whether the product you're handling is contact or non-contact type
• If contact type, confirm the personal electronic thermometer (A21010.03) Class 2 certification procedure
• If non-contact, prepare under the matching item name — ear (A21010.04) or skin (A21010.05)
• If assembling from sub-assemblies, confirm whether a manufacturing license is required
• Cross-check the medical device label and certification number of any product you plan to source or distribute at emed.mfds.go.kr

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Thermometers seem low-risk enough to deprioritize, but this is an item where unlicensed distribution has actually been caught and led to enforcement action. Tell us whether the product you're handling is contact or non-contact, and finished or sub-assembly, and we'll walk you through what procedure applies in a free pre-review.

Sources: MFDS press release (September 9, 2020, republished via Korea.kr policy news) — recommendation to use certified thermometers and explicit statement that thermal-imaging cameras are not recognized as thermometers. Enforcement case of unlicensed non-contact infrared thermometer manufacturing and sale (reported December 23, 2024, YTN Science). Thermometer classifications (electronic thermometer A21010.03; infrared thermometer, ear A21010.04; infrared thermometer, skin A21010.05 — all Class 2) are based on the primary text of Appendix 1 of the "Regulation on Medical Device Items and Class-by-Item Designation" (MFDS Notice No. 2026-18, effective March 9, 2026), confirmed directly via the National Law Information Center PDF. Item classifications and fees are subject to change with notice revisions, and the classification and class of an individual product can vary based on its intended use and operating principle.