Class 1 Notification: Do It Yourself or Hire an Agency? — An Honest Comparison of Time and Cost

Key takeaway — File a Class 1 notification yourself and the only money paid to the government is the statutory fee of KRW 85,000 (e-filing basis). In exchange, your staff member learns and executes the product classification check, the document preparation, and the e-filing procedure firsthand, and the practical lead time typically runs 2–4 weeks. Hire an agency and you pay a service fee from ₩2.0M on top — and what that money buys is the staff member's time otherwise spent on paperwork, plus the experience that lowers the odds of rejection. The fork in the road is not budget: it is whether your product classification is clear, and whether your staff member has the time. This article puts the cost structure of both routes in the same table, then maps where DIY filings stall and the conditions under which an agency delivers real value.

Does DIY really end at KRW 85,000?

In the previous part — Not Everyone Gets to Say ‘Medical Device’ on Coupang, we introduced the Class 1 notification as the legal route to using claims like "treatment" and "medical use." The natural next question follows — "can I file that notification myself?"

You can. Class 1 is the only one of the four classes registered by a "notification" with no technical file review, so on the face of the procedure there is no reason a staff member cannot handle it directly. Start with the money paid to the government.

Item	Statutory fee	Notes
Class 1 product notification	KRW 85,000	E-filing basis
Manufacturing / import business license (if not held)	KRW 144,000 each	A business-level requirement that must precede the product notification — skipped if already held
Sales (rental) business notification (if you also sell directly)	KRW 10,000	Some products and seller types are exempt, so check whether it applies — see the exemption criteria

That is all the "money." A company that already holds its business license and files only the product notification spends KRW 85,000; starting from the business license and going all the way to direct sales, cash outlay ends at around KRW 240,000. The full table of statutory fees by class is published on the regulatory consulting services page.

The problem is the line that never appears in the table: time. A staff member proceeding alone ends up handling all of the following.

• Product classification check — establishing the grounds for which item name and class the product falls under. The single most important task of the whole project; get it wrong and everything after it is redone.
• Business requirements first — the manufacturing or import business license and the quality manager designation come before the product notification. Skipped if already held.
• E-filing setup — registering on the medical device electronic filing portal, enrolling a digital certificate, and learning the structure of the notification form screens.
• Drafting the notification — entering the intended use, shape and structure, raw materials, and manufacturer details without contradicting the manufacturer's documentation.
• Labeling preparation — a draft Korean label. Easy to postpone because it is not a notification document, but it becomes the bottleneck at the distribution stage.
• Rework after rejection — interpreting the reasons for rejection and rebuilding the documents. For a first-time filer, this is the biggest variable.

The statutory processing period is 5 days, but the practical lead time including document preparation typically runs 2–4 weeks. What stretches that range in a DIY filing is not the procedure itself but the learning and rework in the list above.

What are you paying ₩2.0M for when you hire an agency?

At CLARE Partners, the Class 1 notification service fee runs from ₩2.0M. That is more than 20 times the statutory fee of KRW 85,000, so what the money buys deserves a clear-eyed look.

The honest order is to start with what an agency cannot do. The statutory processing period and the speed at which the manufacturer supplies documents are the same no matter who runs the filing. Hiring an agency performs no magic that shrinks 2–4 weeks into a few days.

What the fee buys is three things.

First, your staff member's time. The entire list above moves into the agency's scope; your side hands over product documentation and confirms the content. If your staff member would be learning the procedure on top of their day job, the value of that time is the real thing to weigh against the fee.

Second, experience that lowers the odds of rejection. Where to anchor the grounds for a product classification, and how to word the intended use so it does not contradict the manufacturer's documentation — these are areas where the side that has repeated the procedure holds the advantage. And if a deficiency request still arrives, one round of response is included in the base fee.

Third, guidance to the next step. After the notification come the sales business notification, labeling, and the permissible scope of advertising claims — walked through as one continuous flow. This is what prevents holding a notification certificate and still getting caught on the label at the distribution stage.

DIY vs. agency — side by side in one table

Comparison	DIY	Agency (CLARE Partners)
Cash outlay	Statutory fee KRW 85,000	Service fee from ₩2.0M + statutory fee KRW 85,000 (itemized separately)
Your staff member's time	Everything from learning the procedure to drafting, filing, and handling rejection	Mostly handing over product documentation and confirming content
Practical lead time	Typically 2–4 weeks — varies widely with the filer's experience and any rework	Typically 2–4 weeks — narrower variance when document preparation is the bottleneck
Rejection / deficiency	You interpret the reasons and redraft yourself	One round of deficiency response included in the base fee
Misclassification risk	Your own judgment — if it turns out Class 2, you start over	The class is confirmed first at the pre-review stage
What remains afterward	Procedural know-how accumulates in-house	Your staff member's time, plus guidance on the post-notification steps

The conclusion the table draws is simple. This comparison is not "cheap vs. expensive" — it is "pay with my time or pay with money." And neither side is always the right answer — the conditions below decide it.

Where do DIY filings actually stall?

Companies that attempt the filing themselves do not actually stop at the submission screen. They mostly stop at five points before and after it.

1. Product classification. "We thought it was Class 1, but it was Class 2" is the most expensive accident. Sterile supply, a measuring function, or the mode of body contact can push the class up — and at that moment you are no longer in a review-free notification but in a certification procedure with a technical file review. How to verify the classification is laid out in the Class 1 Medical Device Notification Guide.

2. Business requirements first. Preparing only the product notification and learning too late that the import business license and quality manager requirements come first. When the order flips, the whole schedule you prepared slides.

3. Manufacturer documentation. The shape, structure, and raw material entries in the notification are grounded in the manufacturer's documentation. When an overseas manufacturer sends documents late or in a different format, the staff member has to reconcile the mismatches between the filing and the documents personally.

4. The intended-use entry. The scope of the notified intended use is the scope of what you may legally advertise. If — as covered in the previous part — advertising claims are why you decided to notify, then how this field is written is effectively the point of the whole project, and it is also the field first-time filers find hardest to judge.

5. Labeling and the GMP exception. Postponing the Korean label until it snags at customs clearance or in distribution; and generalizing "Class 1 is KGMP-exempt" only to find the product — a sterile product, say — is one of the exceptions.

Of these five, points 1 and 2 can be checked before you start. If certainty does not come there, getting a pre-review first — rather than diving into document work in that state — reduces the cost whichever route you end up taking.

Which route is rational for our company?

DIY makes sense when

• The product classification is clear — an existing notified product of the identical type exists, and there is no class-raising factor such as sterility or a measuring function
• The product is made in Korea, or the manufacturer's documentation is already in hand
• A staff member can genuinely dedicate time to the procedure
• You plan to notify similar products repeatedly — the first filing's learning becomes an in-house asset

An agency makes sense when

• It is an import case, where the business license prerequisite and overseas manufacturer documentation are entangled
• The classification is ambiguous — products on the Class 1/2 boundary carry the highest misclassification cost
• The launch date is fixed and delays from rework cannot be absorbed
• The staff member wears multiple hats, with effectively no time to learn the procedure

If you are leaning toward an agency, choosing one becomes the next problem. Seven criteria you can use in any consultation — itemized quotes, issued-document track record, staffing structure, and more — are compiled separately in How to Choose a Medical Device Regulatory Consultant in Korea. Other common questions about costs and timelines are answered on the regulatory consulting services page.

What CLARE Partners does

CLARE Partners has split its scope so that whichever route you take at this fork, you can hand over only the parts you need.

• Class 1 notification service — from document preparation to filing, service fee from ₩2.0M (the statutory fee of KRW 85,000 is itemized separately)
• Sales (rental) business notification service — document preparation and filing, service fee from ₩0.5M
• Labeling review — even if you notify yourself, the label alone can be reviewed separately, service fee from ₩0.5M
• Free pre-review — send us your product details and we give a first response on the class, the required procedures, and your document readiness within 1 business day

The full item-by-item fee schedule and quote structure are on the regulatory consulting services page. If you start on your own and hand over midway, we check how far you have progressed and quote only the remaining work.

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If you cannot yet tell whether to file yourself or delegate, the first ingredient for that judgment is confirming the class. Send your product details for a free pre-review and we will start by confirming whether your product qualifies for a Class 1 notification and where a DIY filing would snag — you are free to proceed on your own after the review.

Statutory fees are the amounts in Annexed Table 10 of the Enforcement Rule of the Medical Devices Act (e-filing basis, as amended 1 Jul 2026) and may change when the statutes are amended. Service fees are shown as CLARE Partners' confirmed minimum rates ("from"). The "stall points" in this article are a general classification of practical patterns, not a ranking based on any specific statistics.