The Businesses That Are Not Distribution — Medical Device Lease and Repair Notifications in Korea

Key takeaway — Distribution is not the only medical device business. Leasing and repair exist separately, and the relationship among the three is not quite what intuition suggests. A distributor notification covers leasing, so you do not file again. Repair, by contrast, is an entirely separate notification that demands facilities and a quality system. And servicing devices your own company manufactured or imported falls outside the notification requirement. Compiled in September 2026 directly from the Medical Devices Act and its Enforcement Rule.

The three businesses on one page

	Distribution	Lease	Repair
Basis	Act Article 17(1)	Act Article 17(1)	Act Article 16(1)
Filed with	Local government of the premises	Local government of the premises	Local government of the repair premises
Unit	Each place of business	Each place of business	Repair premises
Processing	3 days (deemed accepted if no notice)	3 days	10 days (deemed accepted if no notice)
Facilities	No separate provision	None	Facilities and quality system (Enforcement Rule Annex 5)
Form	Form 36	Form 36	Form 33

1. Leasing — covered by the distributor notification

Article 17(2) of the Act lists four cases where no notification is required.

1. A manufacturer or importer selling or leasing devices it manufactured or imported to device handlers
2. A person who has filed a distributor notification carrying on a lease business
3. A pharmacy operator or drug wholesaler selling or leasing devices
4. Selling contraceptive devices and self-testing devices used outside a medical institution as prescribed by Ordinance

The second is the one most used in practice. With a distributor notification in hand, starting a lease business requires no fresh filing. The relief runs one way only — starting to sell while holding only a lease notification is not what this provision addresses.

The specific items under the fourth are set by Article 38 of the Enforcement Rule.

• Condoms
• Blood glucose meters whose measuring function is contained in, or combined with, mobile phones and home appliances
• Other devices published by the MFDS Minister having regard to the degree of risk and safety

2. Selling online — a home can be the place of business

Article 37(2) of the Enforcement Rule is not widely known in practice.

A person who, under Article 17(1) of the Act, intends to sell medical devices as a business by electronic commerce or mail order under the Act on Consumer Protection in Electronic Commerce may use a residential building under the Building Act, or a business incubator under Article 18-3(1) of the Special Act on the Promotion of Venture Businesses, as the place of business.

An online-only seller therefore need not take separate commercial premises. The notification is still filed for each place of business, and the remaining requirements covered in the distributor notification guide are unchanged.

Processing takes three days (Act Article 17(4)). If acceptance or an extension is not notified within that period, the notification is deemed accepted the day after it ends (Article 17(5)).

One more point. Where a distributor or lessor files a business closure with the tax office under the Value-Added Tax Act, or its business registration is cancelled, the local government may cancel the notification of its own motion (Article 17(6)). This is how a medical device notification quietly disappears while tidying up a business registration.

3. Repair — a different character from here

Article 16(1) of the Act requires a repair notification from anyone repairing medical devices as a business. A proviso follows.

A person who has obtained manufacturing approval, certification or notification, or import approval, certification or notification, does not file a repair notification for repairing devices the company itself manufactured or imported.

Servicing your own products is therefore not a separate notification matter. The facility requirement, however, remains. Article 16(2) expressly includes "a person who, under the proviso to that paragraph, intends to repair devices the company itself imported" among those who must have facilities and a quality system. The exception is where testing for quality control is outsourced, as prescribed by Ordinance.

The required facilities and quality system are in Annex 5 of the Enforcement Rule (Article 35(4)).

The notification uses form 33, and on acceptance a certificate on form 34 is issued. The register records the acceptance number and date, the type of devices to be repaired, the repairer's particulars, and the name and location of the repair premises (Article 35(2)).

The processing period differs from distribution — 10 days for the notification and 7 days for closure or suspension (Act Article 16(5)). The deemed acceptance on the following day works the same way (Article 16(6)).

4. A repairer's duties — four of them

Article 36 of the Enforcement Rule sets them out.

No.	Duty
1	Do not repair by altering the device away from what was approved, certified or notified (minor change repairs excepted)
2	Where a device has been repaired, record the trade name and address on its container or outer packaging
3	Notify the person who requested the repair of the repair particulars in writing (including any minor change repair)
4	Maintain the facilities and quality system under Article 35(4)

The first is the heart of repair. Repair restores the original state; it does not change the specification. Making the device differ from what was approved moves it closer to unapproved manufacture than to repair.

The second and third are frequently missed. The trade name and address of the repairing company must be written on the container or outer packaging of the device, and the repair particulars must be given to the requester in writing. A verbal explanation is not the form the provision requires.

Article 16(4) also applies Articles 12 (change approval), 13 (compliance duties) and 14(1) (closure) mutatis mutandis, reading "manufacture" as "repair" and "production control" as "repair control". The change-notification and compliance framework therefore follows the repairer as well.

5. Distributor and lessor duties come as a package

Article 18(1) of the Act requires those who may sell or lease medical devices to observe quality assurance methods at the place of business and matters concerning the maintenance of sales order. The substance is Articles 39 and 40 of the Enforcement Rule, covered in detail in the used medical device guide.

Article 18(2) prohibits providing economic benefits. Distributors and lessors, and the sales-promotion agents they engage, may not provide economic benefits to healthcare professionals, medical institution founders or their staff for the purpose of adoption, inducement of use or maintenance of transactions. Samples and the like within the scope prescribed by Ministry of Health and Welfare Ordinance are excepted. Paragraph 3 prohibits entrusting promotion work to anyone who is not a sales-promotion agent.

Common mistakes

• Spending time filing a fresh lease notification when starting to lease — the distributor notification covers it (Act Article 17(2)2)
• Conversely, starting to sell while holding only a lease notification — the relief runs one way
• Reading "no notification for our own after-sales service" as meaning no facility or quality system requirement either (Act Article 16(2))
• Improving performance or specification during a repair (Enforcement Rule Article 36(1))
• Omitting the trade name and address marking and the written repair particulars (Article 36(2) and (3))
• Not realising that cancelling a business registration can cancel the device notification of the authority's own motion (Act Article 17(6))

Pre-filing checklist

• Decide first whether the activity is selling, leasing or repairing
• If a distributor notification exists, confirm that no lease notification is needed
• For an online-only business, consider whether a residence or business incubator may be the place of business (Enforcement Rule Article 37(2))
• For repairs, separate your own products from other companies' — other companies' products require a repair notification
• Even for your own products only, confirm the Annex 5 facilities and quality system
• Prepare forms for the container marking and the written repair particulars
• Map the change-notification triggers (location, representative) and the filing route

---

The boundary among the three businesses turns on the activity itself. Selling, lending and repairing each carry a different filing route and a different facility requirement. Which notification your current business model needs is what we check first in a free preliminary review.