Korea's Medical Device Distribution Quality Standard — What Follows the Distributor Notification

Key takeaway — The distributor notification is the procedure that opens the door; what comes next is the distribution quality control standard in Annex 6 of the Enforcement Rule. It holds seven facility requirements for the storage site, a control manager, incoming and outgoing check procedures, three registers, and twelve hours of annual training. And the line that matters most in practice: a mail-order seller holding no storage site is exempt from a substantial part of it, the facility requirements included. Compiled in September 2026 directly from the annex.

Where the standard comes from

Article 18(1) of the Act requires distributors and lessors to observe quality assurance methods at the place of business, and Article 39 of the Enforcement Rule divides that into four. The fourth is this standard.

Observe the medical device distribution quality control standard in Annex 6. This does not apply where no distributor notification need be filed under Article 17(2) of the Act.

So where the distributor notification is exempt, this standard does not arrive either. The exemptions are covered in the lease and repair guide.

Annex 6 defines the standard as "the detailed criteria that a person who may sell or lease medical devices must observe in connection with distribution."

1. Three words for space, defined first

The annex separates three words for dividing space. The difference decides how facility requirements are judged.

Term	Definition
Separation	A different building, or a space within the same building divided by a wall
Partitioning	Divided by a partition or similar so that contamination or mixing can be prevented
Demarcation	Marked by a line or spaced apart so that devices can be distinguished and not confused

The strength runs separation > partitioning > demarcation. Which word the provision uses decides whether a wall, a partition or a painted line is required.

2. Storage site facilities — seven requirements

Item 2 of Annex 6 sets the criteria for the storage site.

Sub-item	Requirement
(a)	The building is separated from unclean places, and the storage site secures sufficient area and space
(b)	Not to be used for purposes other than the sale or lease business. Non-device products may be stored demarcated or partitioned where this does not impair supply and quality control
(c)	Devices must not rest directly on the floor
(d)	Lighting suitable for handling, and a well-ventilated location
(e)	Facilities maintaining appropriate temperature and humidity to prevent deterioration, with air conditioning where needed. For devices requiring a set temperature, a separate refrigeration or freezing unit fitted with an automatic temperature recorder
(f)	Automatic units to be inspected periodically and kept functioning, with the inspection records retained for one year
(g)	Facilities to exclude pests and rodents, and fire-extinguishing equipment

Sub-item (c) is the one most often cited on inspection. Stacking stock on the floor without pallets or shelving fails the standard on its own.

Sub-item (e) weighs on companies handling refrigerated items. The provision asks not for an ordinary refrigerator but for a unit fitted with an automatic temperature recorder, and (f) requires those records to be kept for one year.

3. The control manager — the representative may hold the post

Item 3 requires a control manager to be appointed to check and confirm performance under the standard, and adds one line:

In this case the representative may hold the position of control manager concurrently.

This is a different position from the statutory quality manager at a manufacturing or import site. No qualification requirements are listed in the text, and no separate hire is required. That sentence is why a small distributor can start with the representative alone.

4. From receipt to shipment — eight items

Item 4 sets the quality and environmental hygiene controls.

• On receipt — verify the counterparty, model name, quantity and specification of the goods against the purchase order or transaction statement, and carry out a visual inspection for damage and contamination
• Devices requiring separation by storage temperature to be stored separately in refrigerated or frozen areas
• Returned and defective devices to be stored separately
• On shipment — an operator must be present in person to carry out a visual quality check and verify counterparty, model name, quantity, specification and use-by date before shipping, and where the sale is to a medical institution, distributor or lessor, the sale must be recorded
• Devices requiring temperature separation to be kept at the appropriate temperature in transit
• The storage site, machinery, equipment and facilities to be kept clean
• Complaints received in the course of distribution to be investigated promptly, addressed appropriately and recorded
• Where a lessor leases a body-contact device requiring contamination control, contamination must be removed by cleaning and disinfection and the fact recorded and managed in writing

The last is a duty specific to leasing. If the business takes back devices that touch the body and lends them out again, the cleaning and disinfection record is itself a regulated item.

5. Three registers and two-year retention

Item 5 prescribes three registers to be prepared and kept on site.

Register	Content	Basis
Facility and equipment register	Results of the facility and equipment checks under item 2	Item 5(a)1)
Shipping register	The sales records under the second sentence of item 4(d)	Item 5(a)2)
Complaint register	Receipt and handling of complaints under item 4(g)	Item 5(a)3)

Sub-item (b) sets the retention — except as otherwise provided by law, records of business handling including the registers must be kept for two years.

These are different provisions from the two-year inspection record and one-year defect record covered in the used medical device guide, so the registers must be managed separately.

6. Training — twelve hours a year

Item 6 requires an in-house training plan for staff development and at least one session per quarter totalling twelve hours a year.

Five subjects must be covered:

• Responsibility in handling medical devices
• The substance and specifications of the devices
• Handling and quality control
• Relevant legislation
• Anything else needed to carry out the standard effectively

Note that "at least once per quarter" and "twelve hours a year" bind together. Twelve hours crammed into December breaks the quarterly requirement.

7. A mail-order seller with no warehouse — a substantial part falls away

This is the most practical passage in the guide. Item 7 provides:

For a medical device mail-order seller that holds no storage site, item 2, item 4(b), (c), (e) and (f), and item 5(a)1) do not apply.

The annex defines a medical device mail-order seller as "a person with a distributor notification under Article 17 of the Act who engages only in mail order under Article 2(2) of the Electronic Commerce Act."

Separating what falls away from what remains:

	Mail-order seller with no storage site
Item 2, the seven facility requirements	Not applicable
Item 4(b) temperature separation, (c) returns and defects, (e) transit temperature, (f) cleanliness	Not applicable
Item 5(a)1) facility and equipment register	Not applicable
Item 3 control manager	Applies
Item 4(a) receipt checks, (d) shipment checks and sales records, (g) complaints, (h) cleaning on lease	Applies
Item 5(a)2) shipping register, 3) complaint register, (b) two-year retention	Applies
Item 6 twelve hours of annual training	Applies

The premise is holding no storage site. The business must not carry stock itself; orders must ship from the supplier. The moment a warehouse is used, item 2 revives. Read alongside Article 37(2) of the Enforcement Rule, which allows a residence as the place of business for online sales, it shows that online selling without stock is designed with a low entry threshold.

Common mistakes

• Completing the notification and never reading Annex 6 — the notification is the start and the standard is what follows
• Stacking devices directly on the floor (item 2(c))
• Using an ordinary refrigerator for refrigerated items — the text requires an automatic temperature recorder
• Managing the inspection records (one year) and the register records (two years) on a single retention rule
• Running twelve hours of training in December — the quarterly requirement binds too
• Believing the mail-order exception applies while using a warehouse (item 7 presumes no storage site)
• Running a lease business without written cleaning and disinfection records (item 4(h))

Pre-launch checklist

• Confirm the distributor notification is not exempt (if exempt, this standard does not arrive either)
• Do you hold stock? If so, walk the seven requirements of item 2 through the actual site
• For refrigerated items, confirm the automatic temperature recorder and the one-year inspection records
• Appoint a control manager (the representative may hold the post)
• Create the three registers and set the two-year retention rule
• Draw up the training plan and schedule one session per quarter, twelve hours a year
• For a lease business, create a separate cleaning and disinfection record form
• For mail order only, be able to document that no storage site is held

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The distribution quality standard outlives the notification. The filing takes a day; the facilities, registers and training come round every year. How many items actually apply to your business model, and whether your structure qualifies for the mail-order exception, is what we check first in a free preliminary review.