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. Contact-type electronic thermometers are Class 2 ("personal electronic thermometer," A21010.03) and require certification; non-contact (infrared) thermometers are also managed as a separate item. 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 plus review-agency fees are added as separate actual costs. The overall Class 2 procedure is covered in the Class 2 Certification Cost Guide.

Non-contact (infrared) — the class needs primary-source confirmation

Non-contact thermometers are also managed as medical devices. In a September 2020 announcement, MFDS stated that anyone measuring and recording individual body temperature should use an MFDS-certified thermometer, without distinguishing contact from non-contact.

That said, this guide does not state the specific item-classification number and class for non-contact thermometers. Appendix 1 of the regulation is only available as an attached file, and it could not be confirmed from a primary source. Don't assume it shares the same Class 2 status as the contact type — get an official item-classification confirmation at the preparation stage instead.

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
• Assuming a non-contact thermometer shares the contact type's class without confirming it
• 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, get an official item-classification confirmation first (don't guess the class)
• 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). The Class 2 classification of the contact-type electronic thermometer (A21010.03) is based on Appendix 1 of the "Regulation on Medical Device Items and Class-by-Item Designation" (MFDS Notice No. 2026-18, effective March 9, 2026) — per the primary text on the National Law Information Center. The specific item-classification number and class for non-contact thermometers could not be confirmed from Appendix 1's primary text (an attached file) and is not stated in this guide. 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.