A Class 1 Device That Still Needs KGMP — Sterile Products

Key takeaway — A Class 1 medical device can be excluded from the KGMP conformity assessment (Article 3(2)2 of the notification). But the provision reads: one shall "follow this standard, but the assessment may be excluded" — what is waived is the assessment, not the quality management standard. For sterile products, the sterile-workplace facility requirements and sterilization validation remain in full, and when exports or a buyer demand a certificate of conformity, even Class 1 devices take the assessment voluntarily. On top of that, sterility can change the class designation itself — shaking the very premise that you hold a Class 1 device. The order to verify is: is it really Class 1 → where will it be sold → does the manufacturing site meet the requirements.

"It's Class 1, so KGMP isn't our problem" — only half right

This is the first point of relief for anyone new to Korean medical device registration: "Our product is Class 1, so a notification is all we need — no KGMP." As laid out in the earlier Class 1 medical device notification guide, Class 1 is indeed the only one of the four classes that ends with a review-free "notification," and it is true that it can also be excluded from the KGMP conformity assessment.

Read the underlying provision as written. Article 3(2) of the Regulation on Medical Device Manufacturing and Quality Control provides that, notwithstanding the general scope of application, in certain cases one "shall follow this standard, but may be excluded from the conformity assessment" — and its items include manufacturing or importing a Class 1 medical device (item 2). The same goes for periodic audits: a Class 1 device may skip the periodic audit even after obtaining conformity recognition (Article 4(3)2 of the same notification).

The trouble begins the moment you read that sentence as "Class 1 has nothing to do with KGMP." What the provision designates for exclusion is the conformity assessment — the procedure in which an auditing body reviews documents, inspects the site, and issues a certificate of conformity. The phrase in front of it is the key: "shall follow this standard." The standard (the quality management standard) itself must be followed; only the gate called the assessment can be waived.

What is waived is the "assessment," not the "standard" — what sterility leaves behind

That is why sterile products are tricky. Even with the assessment waived, the standard you still must follow contains sterilization requirements. They show up at two levels.

First, facility requirements for the manufacturing site. Annex 2 of the Enforcement Rule of the Medical Devices Act (standards for facilities and the manufacturing and quality management system) requires that, in a workplace manufacturing products that require sterilization, the ceiling be finished so that no dust can fall, the floor and walls be smooth so that dust and dirt are easily removed, the surfaces of ceiling, floor, and walls withstand spray cleaning with disinfectant, and the workplace be equipped with sterilization facilities (Annex 2, item 1(b)). Facility requirements that never applied to an ordinary Class 1 product attach for the single reason of sterility.

Second, particular requirements in quality management. Annex 2 of the Regulation on Medical Device Manufacturing and Quality Control requires, for sterile medical devices, that records of the process parameters be maintained for each sterilization batch (7.5.5) and that procedures for the validation of processes for sterilization and sterile barrier systems be documented (7.5.7). If you do end up taking the assessment — voluntarily, or because the class moved up — the application stage requires submission of the sterilization validation procedures and sterilization evidence (Article 7(1)2, items (e) and (g), of the same notification).

In short, "waived assessment" and "waived requirements" are different things. For sterile products, the gap between the two is at its widest.

Item	Class 1 general principle	If the product is sterile
Conformity assessment (certificate of conformity)	May be excluded (Article 3(2)2 of the notification)	Taken voluntarily when exports or buyers require it (Article 5(2)3 of the notification)
Compliance with the quality management standard	"Shall follow this standard" — the duty remains	Particular requirements added, e.g. sterilization process validation (Annex 2 of the notification, 7.5.5 and 7.5.7)
Manufacturing site facilities	Ordinary workplace and storage	Sterile-workplace ceiling and wall specs + sterilization facilities (Enforcement Rule Annex 2, item 1(b))
Product class	Subject to notification	Sterility can affect class designation → Class 2 means certification

Then why would a Class 1 device take the assessment at all — voluntary, buyer-driven

The provisions also leave a path for a Class 1 device to "opt in" to the assessment. Article 5(2)3 of the Regulation on Medical Device Manufacturing and Quality Control provides that, notwithstanding Article 3(2), where a Class 1 medical device seeks the conformity assessment under this standard, certain items of Annex 2 apply (4.1, 4.2, 5.5, 6.4, 7.1, 7.4, 7.5, 7.6, and so on). The waiver is a right, not a prohibition — you can choose to take the assessment when you need it.

When would you take that path? Above all, for exports. When a foreign regulator or buyer asks for a quality management system certificate of conformity (or documentation based on one), companies obtain the certificate through a voluntary conformity assessment even though Class 1 is exempt domestically. A document you never needed for domestic distribution becomes a condition of doing business the moment the sales channel opens overseas.

This is where sourcing and export plans intersect. Depending on where you intend to sell your sterile Class 1 product, KGMP shifts in character from "something you can skip" to "something worth having in hand."

The most common misreading — is my sterile product really Class 1?

Everything above rests on one premise: that the device really is Class 1. With sterile products, that premise is precisely what most often gives way.

Classes are designated per sub-classified product category, not per product. Annex 1 of the Enforcement Rule (classification criteria) divides classes by potential risk — whether the device is inserted into the body, the duration of insertion or implantation, the presence of biological effect — and provides that where a device falls under two or more classes, it is classified at the highest risk level. The word "sterile" is not itself listed among the classification criteria, but each product category's class is designated per sub-classified category in the Regulation on Medical Device Product Categories and Class per Category, and there are categories whose designation does reflect whether the product is supplied in a sterile state. Among injection needles, the reusable non-sterile needle (A53010.01) is Class 1 while the single-use sterile needle (A53010.02) is Class 2; likewise for acupuncture needles, the non-sterile needle (A84010.01) is Class 1 and the sterile needle (A84010.02) is Class 2.

The practical conclusion is a single line: if "we thought it was Class 1, but it is Class 2 because it is sterile," the entire discussion above changes. Before debating the assessment waiver, you may need to run the Class 2 certification procedure from the beginning. In that case, KGMP is not an option but a precondition for certification.

Just as a change of wording on a product listing can move the boundary between an industrial product and a medical device by changing the intended use (not everyone may use the words "medical device" on Coupang), the single process step called sterilization can change the class and the KGMP burden. What draws the boundary is classification, not material.

What to check now — a 3-step self-check for sterile products

Step 1 — Reconfirm the class. Check the designated class by product category name and intended use. If the product is supplied sterile, re-verify the very premise of "Class 1." If it turns out to be Class 2, the route is certification, not notification, and KGMP is a precondition.

Step 2 — Confirm the sales channels. Domestic distribution only, or exports as well? If there are exports or overseas buyer demands, consider the track of voluntarily securing a certificate of conformity even at Class 1 (Article 5(2)3 of the notification).

Step 3 — Confirm the manufacturing site requirements. Assessment or no assessment, a product that requires sterilization must meet the sterile-workplace facility requirements and have sterilization validation procedures in place. The crux is not mistaking "waived assessment" for "waived requirements."

The full picture of procedures, timelines, and costs by class is laid out in the class-by-class procedure overview, and KGMP as a whole in the KGMP guide.

What CLARE Partners does

CLARE Partners starts by verifying the very judgment "it's Class 1, so no KGMP" — before you file.

• Free pre-review — Send us the product category name, intended use, sterility status, and sales channels, and we give a first response within 1 business day on the designated class, whether KGMP is needed, and the required procedure
• Class 1 notification service — From document preparation to filing, service fee from ₩2.0M (the statutory government fee of KRW 85,000 is itemized separately)
• Manufacturing KGMP service — Quality system documentation, on-site audit preparation and response, through to completed conformity recognition, service fee from ₩8.0M (auditing body fees are itemized separately at cost)

The full item-by-item fee schedule and quote structure are on the regulatory consulting services page.

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Most of a sterile product's KGMP burden is settled the moment the class is settled. The cheapest time to make that judgment is at the stage of confirming the product class — not after detailed design and sourcing are done. Send your product information, sterility status, and sales channels through a free pre-review, and we will start by confirming whether it really is Class 1 and how far KGMP actually reaches.

Legal basis: Regulation on Medical Device Manufacturing and Quality Control (MFDS Notification No. 2026-46, effective July 1, 2026) Articles 3, 4, 5 and Annex 2 · Enforcement Rule of the Medical Devices Act (Ordinance of the Prime Minister No. 2127, effective July 1, 2026) Annex 2 (standards for facilities and the manufacturing and quality management system, under Article 8(1)) and Annex 1 (criteria and procedures for the classification and designation of medical devices, under Article 2) — Based on the original texts of the National Law Information Center and MFDS notifications; the content may change as statutes and notifications are amended. Class designations per product category follow the Regulation on Medical Device Product Categories and Class per Category.