Reselling Used Medical Devices in Korea — The Rules Turn on Where You Bought It, Not on It Being Used

Key takeaway — Look for a "used medical device sales licence" in Korea and you will not find one. The provisions barely use the word "used". They regulate instead by restricting who you may buy from and attaching an inspection duty to devices bought from a medical institution. Four things matter in practice: where you may buy, inspection and the inspection tag, what may not even be displayed, and how long records must be kept. Compiled in September 2026 directly from the Medical Devices Act and its Enforcement Rule.

1. The distributor notification comes first, used or not

Anyone selling medical devices as a business must file a distributor notification for each place of business with the head of the local government where the premises sit (Act Article 17(1)). New or used makes no difference.

The exemptions are listed in Article 17(2) — a manufacturer or importer selling or leasing its own devices to device handlers, a person with a distributor notification carrying on a lease business, a pharmacy operator or drug wholesaler selling or leasing devices, and the sale of contraceptive devices and self-testing devices used outside a medical institution as prescribed by Ordinance.

Processing is quick. The local government must notify acceptance within three days of receipt (Article 17(4)), and if it does not, the notification is deemed accepted on the day after that period ends (Article 17(5)). The procedure itself is covered in the distributor notification guide.

2. Where you may buy — the first gate

Article 40(1) of the Enforcement Rule restricts the purchase source.

Devices shall not be purchased from a person who is not a manufacturer, importer or distributor. Purchases from a medical institution are excepted.

That leaves four permitted sources.

Source	Permitted
Manufacturer	Yes
Importer	Yes
Another distributor	Yes
Medical institution	Yes (express exception)
Private individuals, closed businesses, individual sellers on marketplaces	Not a route the provision contemplates

Most failures in the used-device trade start here. Buy cheaply from an individual and the inspection and tag procedure that follows never gets off the ground.

3. Bought from a medical institution — inspection and the tag

Article 39(1) of the Enforcement Rule sets three duties where a device is bought from a medical institution.

Item	Duty
(a)	Send the device for inspection to its manufacturer or importer, or to a designated medical device testing body
(b)	Sell or lease only devices that received the inspection tag issued on that inspection
(c)	Where the inspection produces an instruction on sale or lease, observe it

The duties of the party asked to inspect are also in the text.

• Manufacturer — Enforcement Rule Article 27(1)16. It inspects against the manufacturing and quality-system criteria in Annex 2, item 2, and issues an inspection tag only where the device conforms. The issuing procedure, method, response time and any sale or lease instructions are set by MFDS notification
• Importer — Enforcement Rule Article 33(1)20, on the same structure

Where a manufacturer or importer buys back its own product from a medical institution, the inspection duty falls on it directly (Article 27(1)15, Article 33(1)19). It may attach the inspection tag and ship only on a conforming inspection, and must record the inspection content, result and tag issue date and keep that record for two years from shipment.

Importers carry one extra line. Article 33(1)19 covers "importing a used medical device or buying back from a medical institution a device the company itself imported." Bringing used equipment in from abroad falls here.

4. What may not even be displayed

Article 40(3) prohibits not only sale and lease but storage and display for the purpose of sale or lease, of:

• a device without the inspection tag under Article 39(1)(b)
• a device that is contaminated or damaged, or that the MFDS or a regional office has ordered collected or disposed of
• a device whose use-by or expiry date has passed

Article 40(4) prohibits selling, or storing or displaying for sale, devices not approved, certified or notified.

In other words, "put it on the floor now and inspect it when it sells" runs against the text. Inspection comes first, display second.

5. Records — two years and one year

Record	Retention	Basis
Inspection content and result, tag issuer and issue date, sale or lease instructions	Two years from the sale date	Enforcement Rule Article 39(2)
Handling of defective devices	One year from the record date	Article 39(3)
(Manufacturer or importer) inspection content and result, tag issue date	Two years from shipment	Article 27(1)15(b), Article 33(1)19(b)

Article 39(4) adds one more — observe the medical device distribution quality control standards in Annex 6, except where a distributor notification need not be filed under Article 17(2) of the Act.

6. When the inspection tag is waived

Article 41 (Waiver of the inspection tag for used medical devices) provides that, notwithstanding Article 27(1)15, Article 33(1)19, Article 39(1)(b) and Article 40(3)(a), devices of low potential risk and others published by the MFDS Minister may be sold without an inspection tag.

Confirming whether your product category appears in that published list is the first step in designing the business. If it does, the inspection cost and the waiting time for a response disappear; if it does not, that time goes straight into your inventory turnover.

7. Breach — business is suspended item by item

The administrative disposition table in the Enforcement Rule treats an importer's breach of Article 33(1)19 as follows.

• Failing to inspect, or shipping without attaching the tag — first offence: suspension of sales of that item for one month; second: three months; third: six months; fourth: revocation of the import approval or certification for that item, or an import ban
• Failing to prepare, keep or retain records — 15 days, one month, three months, six months

Note that the disposition lands on the item, not on the company as a whole. If your lead item stops, the business stops.

Common mistakes

• Buying from an individual and only then trying to run the inspection and tag procedure (Article 40(1))
• Sending the inspection to any laboratory — the provision names the device's own manufacturer or importer, or a designated medical device testing body
• Displaying stock before inspection (Article 40(3)(a))
• Obtaining the tag but omitting the two-year record retention (Article 39(2))
• A manufacturer or importer buying back its own product from a hospital without realising the inspection duty falls on it (Article 27(1)15, Article 33(1)19)
• Importing used equipment without reviewing Article 33(1)19

Pre-launch checklist

• Is the distributor notification filed for each place of business (Act Article 17(1))?
• Is the purchase source a manufacturer, importer, distributor or medical institution?
• Has it been checked whether the product category appears in the Article 41 waiver list?
• If not waived, has an inspection route been secured in advance?
• Is the tag response time built into the inventory turnover plan?
• Is there a form and an owner for retaining inspection records two years from the sale date?
• Is there a defective-device handling record form (one year)?
• Has Annex 6, the distribution quality control standard, been read?

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Success in the used-device trade turns not on price but on the purchase source and the inspection response time. Whether your product category is waived from the tag, and whether your buying route sits inside the provision, is what we check first in a free preliminary review.