Korean Medical Device Approval by Product Type — a Quick Guide to 16 Frequently Asked Item Families

Key takeaway — Whatever the product, one principle holds: item classification sets the class, and the class sets the procedure (notification, certification, or approval). This page gathers 16 frequently searched item families with their name variants and decision forks, and points to what to check first for each. Where we do not state a class, that is deliberate — the same product name can fall under different items depending on intended use and structure. How to check item classification is the common starting point. Verified as of August 2026.

The common structure — what "item × procedure" searches really mean

Search combination	What it actually is
Item + notification/certification/approval	The product route set by class — Class 1 notification · Class 2 certification · Class 3–4 approval (overview)
Item + import	The company's import business license plus the class-based product route — two tracks
Item + KGMP	Conformity assessment of the manufacturing site — effectively a set for Class 2 and above
Item + technical file	The technical file at the heart of review — item characteristics land here

Quick guide by item family

Thermometers — household electronic thermometers are Electronic thermometer (A21010.03), Class 2, a certification item.

Nebulizers — including mesh and medical nebulizers; typically Class 2 range — see the nebulizer guide.

Catheters — medical and urological catheters split by use, contact site, and dwell time; classification first.

Medical freezers — medical freezers, blood-bank freezers, ultra-low freezers. Regulatory status depends on whether medical purposes (blood or specimen storage) are claimed — check classification before planning approval, certification, import, or KGMP.

Nasal irrigators — nasal cleansers, rinsing kits. A boundary family where device status itself follows the claims: whether it is a notification item, an approval item, or a consumer product is decided by wording — a pre-contract check for importers.

Rehabilitation robots and exercise devices — rehabilitation robots, rehabilitation exercise equipment, powered orthopedic exercise devices, medical steppers. Robots are composite-review items typically in the Class 2–3 range (guide); for exercise devices, check the item definitions.

Wheelchairs — the manual wheelchair is a flagship Class 1 notification item (notification and import notification); powered models need a separate certification check.

Biopsy and puncture needles — invasive, sterile products; see the FAQ above.

Medical suction devices — including low-pressure continuous suction units. The same word covers home/clinical inhalers and surgical suction devices — regulatorily different products; see the inhaler/suction fork guide.

Breast pumps — including electric models; see the FAQ above.

Medical clamps — surgical clamps split by material and use; classification decides whether notification suffices or approval is needed, and importing adds the business license track.

Supports and braces — medical lumbar supports. A boundary family split by claims ("posture correction," "pain relief"); classification and claims decide whether notification or approval applies.

Pregnancy test kits — an in-vitro diagnostics family governed by the separate IVD Medical Devices Act; note that selling self-testing devices is exempt from the sales business notification (sales guide) — separate from the product route itself.

Software and AI — software as a medical device (SaMD), digital medical devices, AI medical devices, medical software. Software alone can be a medical device — the SaMD guide is the dedicated reference.

How to use this page

1. Find your item family above and check the name variants and decision forks.
2. Confirm the class through item classification — this far you can go on your own.
3. With the class confirmed, the combination table above becomes your schedule. Timelines and costs are published in the overview by class.

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Send us the product name and the claims (listing page or brochure) and the free preliminary review will map the classification candidates, the class, and the procedure combination — product route, import business license, and KGMP scope.