IVD Registration and Distribution in Korea — Which Licences an Overseas IVD Manufacturer and a Korean Distributor Each Need

Key takeaway — In vitro diagnostic devices (IVDs) in Korea have been governed first by the In Vitro Diagnostic Medical Devices Act since 2020, with anything that Act does not provide falling back to the Medical Devices Act (Article 4). Importing and selling one takes three layers. ① The import business licence (Article 11(1)) and the item-level import licence, certification, or notification (Article 11(2)) are obtained in the name of an importer with facilities, a quality management system, and a quality manager in Korea; ② the sales business notification follows Article 17 of the Medical Devices Act, with a possible exemption for self-testing products; and ③ labels and package inserts carry three items that the general-device list does not (Article 13). The overseas manufacturer's job is the dossier for ① and the choice of licence holder; the Korean distributor's job is ②. An exemption from the sales notification does not remove the import procedure.

Why IVDs have to be read separately — two statutes

In vitro diagnostic devices are the reagents, calibrators and controls, instruments, and software used to examine specimens taken from humans or animals outside the body (IVD Act, Article 2, subparagraph 1). Since 2020 they have been governed by their own statute, and anything that statute does not provide is governed by the Medical Devices Act (Article 4). So every procedure has to be read in two steps — first, is there a provision in the IVD Act; if not, which article of the Medical Devices Act applies. Business licences, item procedures, and labeling sit in the first Act; much of sales, advertising, and post-market control falls back to the second.

How the class criteria and the name of the clinical evidence differ is covered in our IVD guide. This article answers the next question: who needs which licence.

To import — the import business licence and the item procedure

Anyone intending to import IVDs as a business must obtain an import business licence from the MFDS, and the holder is then deemed an importer under the Medical Devices Act for IVDs only (Article 11(1)). The importer must obtain an import licence or certification, or file an import notification, for each item it intends to import (Article 11(2)), and at least one item must be filed together with the import business licence application (Article 11(3)). Low-risk products designated by MFDS notification go through the procedure by item group; everything else by item (Article 11(2), subparagraphs 1 and 2).

Layer	What	Basis	In whose name
Company	Import business licence	Article 11(1)	The Korean importer
Product	Item-level import licence, certification, or notification	Article 11(2)	The same importer
Facilities and system	Quality-inspection facilities and a manufacturing and quality management system	Article 11(4)	Put in place by the importer beforehand (Ordinance exceptions such as outsourced testing)
People	Quality manager	Article 5(8), applied through Article 11(5)	Appointed by the importer

The decision on the import business licence is notified within 25 days of the application, and if no notice is given within that period the licence is deemed granted on the following day (Article 5(9) and (10), applied through Article 11(5)). Where a material matter affecting safety or effectiveness changes, a change licence, change certification, or change notification is required; other changes must be recorded and reported (Article 10, applied through Article 11(5)).

The importer submits manufacturing and quality management system data, the technical file, and clinical performance study data (Article 5(6), applied through Article 11(5)). The evidence is called a clinical performance study, not a clinical trial as for general devices, and the IVD Act sets its own approval procedure and institution designation (Articles 7 and 8). This is where overseas manufacturers most often prepare the wrong thing — overseas performance evaluation data may exist, but whether it is structured to Korean requirements has to be checked first.

Who holds the licence — for an overseas manufacturer

The item licence is issued in the name of the Korean importer, not the manufacturer. Because the importer must have facilities, a quality management system, and a quality manager in Korea, a manufacturer without a Korean entity chooses between a subsidiary, a distributor that takes on the import business, and an independent licence holder (ICC). Where the licence ends up in each structure, and what to put in the contract first, are in the KLH and ICC structure guide; the full seven-step sequence is in the registration path for overseas manufacturers. Being an IVD does not change that structure.

To sell — the sales notification falls back to the Medical Devices Act

The IVD Act has no provision on sales businesses, so sales follow Article 17 of the Medical Devices Act (Article 4). Anyone intending to sell as a business files a sales business notification with the head of the local government for each place of business (Medical Devices Act, Article 17(1)), and acceptance is notified within three days (Article 17(4)). The notification may be dispensed with in the following cases (Article 17(2)):

• a manufacturer or importer selling what it manufactured or imported to another medical device handler (subparagraph 1)
• a pharmacy owner or pharmaceutical wholesaler selling devices (subparagraph 3)
• selling contraceptive devices prescribed by Ordinance and self-diagnostic devices used outside medical institutions (subparagraph 4)

Where a self-testing IVD — a pregnancy test kit, a self-test kit — falls under subparagraph 4, an online seller may sell it without a sales notification. This is where the misunderstanding starts. The exemption concerns the sales notification; it does not remove the import business licence and the item procedure for bringing the product in. Even a product that a seller can sell without notifying must already have entered Korea under someone's import business licence and item licence. The pregnancy test kit guide walks through that distinction on a concrete product, and the cases where the sales notification is required or exempt are in the sales business notification guide.

Role	What is needed	Basis
Overseas manufacturer	Technical file, clinical performance study data, quality management system data; choice of licence holder	Article 11(5) (applying Article 5(6))
Korean importer (licence holder)	Import business licence + item licence, certification, or notification + facilities and quality manager	Article 11
Korean distributor	Sales business notification (exemptible for self-diagnostic devices and others)	Medical Devices Act, Article 17
Hospital or testing institution (in-house test)	Certification of the laboratory's in vitro diagnostic testing	Article 12

Labels and package inserts — three extra items

The container or outer casing must carry the items of Article 20 of the Medical Devices Act (except the words "medical device") plus the intended use, the words "in vitro diagnostic medical device", and the storage or preservation method (Article 13). Where outer packaging hides the markings, the same items go on the outer packaging (Article 14), and the package insert must carry directions and precautions together with quality-control instructions where QC is required (Article 15(1)). The insert may be provided as a leaflet, USB, or CD; provision via a website is limited to products mainly used in medical institutions and designated by the MFDS (Article 15(2)). The IVD Act has no provision on the language of markings, so the Korean-language rule of Article 23 of the Medical Devices Act applies as it stands (Article 4).

Use the general-device label checklist unchanged and these three items go missing. The general-device items, and the ones most often omitted, are in the labeling guide; add the three IVD items on top and you have the IVD checklist.

Laboratory-developed tests — certification under Article 12

A medical institution or genetic testing institution that intends to perform tests prescribed by Ordinance using an in vitro diagnostic testing system it designed and configured for use only within its own clinical laboratory must obtain certification of the laboratory's in vitro diagnostic testing from the MFDS (Article 12(1)). The MFDS evaluates the laboratory's quality management system, the proficiency of its staff, and the performance of the devices before certifying (Article 12(2)), and once certified, the IVD devices included in that system are deemed to have obtained manufacturing or import approval, certification, or notification only where they are used within that laboratory (Article 12(3)). Sell the test outside the laboratory and the exception ends; the ordinary procedure applies. Certified institutions must report annual test volumes, keep test records, and maintain the quality system (Article 12(4)), and failing the criteria or breaching those duties is grounds for revoking the certification (Article 12(6)).

Sanctions — revocation and fines

Manufacturing or importing without approval, certification, or notification; failing to maintain the facilities and quality management system; skipping the change procedure; and incorrect markings under Articles 13 to 15 are each grounds for revoking the licence or certification, prohibiting manufacture, import, or sale of the item, or suspending business for up to one year (Article 18(1)). Incorrect markings also carry a fine of up to KRW 5 million (Article 31, subparagraph 1), and failing to obtain a change licence or certification or to file a change notification rises to imprisonment of up to three years or a fine of up to KRW 30 million (Article 29(1)4).

Common mistakes

• Reading the sales exemption as an import exemption — a self-testing product may be sold without notification, but someone still needs the import business licence and the item procedure
• Assuming the general-device import licence covers IVDs — a separate import business licence under the IVD Act is required (Article 11(1))
• Preparing "clinical trial" data — the evidence this Act asks for is a clinical performance study, with its own approval and institution system
• Using the general-device label checklist as is — the intended use, the words "in vitro diagnostic medical device", and the storage method go missing
• Signing the distribution agreement before deciding the licence holder — the item licence stays in the importer's name

Before you start

• You have confirmed the product meets the IVD definition (Article 2, subparagraph 1) and whether the item-group or item procedure applies
• You have decided which company obtains the import business licence and confirmed its facilities and quality manager
• You have listed the technical file, clinical performance study data, and quality management system data and checked them against Korean requirements
• For each sales channel, you have checked whether a sales notification is required or the self-diagnostic exemption applies
• Labels and inserts carry the intended use, the words "in vitro diagnostic medical device", the storage method, and QC instructions
• You have a rule for deciding when a change requires a change licence, certification, or notification

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IVDs are the product group where "which Act, which article" has to be read in two steps every time. Send us the product specification, specimen type and intended use, and your sales plan, and we will tell you within one business day which import business licence and item procedure applies, whether the sales notification is exempt, and where to place the licence — through a free pre-review.

Legal basis: In Vitro Diagnostic Medical Devices Act (Act No. 19920, in force 3 Jan 2026) — Article 2 (Definitions) · Article 4 (Relationship to Other Acts) · Article 5 (Licence for Manufacturing Business, etc.) · Article 7 (Clinical Performance Studies, etc.) · Article 10 (Change Licences, etc.) · Article 11 (Licence for Import Business, etc.) · Article 12 (Certification of In Vitro Diagnostic Testing by Clinical Laboratories, etc.) · Articles 13–15 (Markings) · Article 18 (Revocation of Licences and Suspension of Business, etc.) · Articles 29 and 31 (Penalty Provisions) · Addenda (Act No. 16433), Article 3; Medical Devices Act (Act No. 21949, in force 15 Sep 2026) — Article 17 (Notification of Sales Business, etc.) · Article 23 (Precautions for Markings). Texts confirmed on 22 Sep 2026 in the National Law Information Center; the content may change as the legislation is amended.