Common Reasons a Class 1 Notification Gets Rejected in Korea

Key takeaway — A Class 1 notification skips the technical file review; it does not skip the notification requirements or the check of what you entered. That is where rejections and deficiency notices come from. The patterns we see most often in practice fall into five groups — item misclassification, inconsistencies between the notification and the manufacturer's documents, intended use beyond the item definition, missing prerequisites such as the business licence, and missing or malformed attachments. What they share is that most are checkable before submission. The real cost of a rejection is not a penalty — it is the time spent rewriting. Read the stated reason by pattern, and realign the underlying documents first, not the notification form.

A notification with no review — so why does it get rejected?

In the previous instalment — Class 1 notification: do it yourself or use an agency? we compared the cost structures of the two routes and named "rework after a rejection" as the biggest variable on both. This instalment takes that variable head on — what exactly goes wrong to cause a rejection?

First, a misconception to clear away: "Class 1 has no review, so filing is the end of it." What Class 1 lacks is the technical file review — not scrutiny altogether. Whether the entries in the notification match the submitted documents, whether the item classification you filed matches what the product actually is, and whether preconditions such as the business licence requirements are in place are checked in a notification too. Where a requirement is off, a deficiency notice tells you to fix and resubmit; where a requirement cannot be met, the notification is not accepted.

In this article "rejection" is used broadly — every case, deficiency notices included, where the filing fails to be accepted in one pass and comes back. The statutory processing period is 5 days, yet the practical lead time is typically 2–4 weeks — and this is exactly why. Document preparation and rework decide the timeline; the processing period does not.

What do the common rejection and deficiency reasons look like?

The reasons we encounter in practice sort into roughly five patterns. This is a classification, not a statistic — the point is not which pattern ranks where, but which patterns your own notification is exposed to.

Pattern	What went wrong	Prevention point
1. Item misclassification	The item name or class filed differs from what the product actually is — sterile supply or a measuring function makes it Class 2	Fix the classification basis before drafting any documents
2. Inconsistency between documents	Shape, structure, raw materials, or model names in the notification differ from the manufacturer's documents	Get the manufacturer's documents first, and draft the notification on top of them
3. Intended use beyond the item definition	An intended use outside the item definition is entered	Stay inside the item definition, and keep advertising copy separate
4. Missing prerequisites	Business requirements — import business licence, quality manager — are not in place	Business licence and notifications before the item notification
5. Missing or malformed attachments	Required documents missing, or supporting documents failing format requirements	Cross-check the attachment list item by item before submitting

1. Item misclassification — the most expensive pattern. "We thought it was Class 1; it turns out to be Class 2." Sterile supply, a measuring function, or how the device contacts the body can push the class up — and at that moment the track itself changes, from a review-free notification to a certification procedure with a technical file review. A large share of the documents you prepared has to be rebuilt, so the rework here is the widest of the five patterns. How to verify the classification is laid out in the Class 1 medical device notification guide.

2. Inconsistency between documents — the pattern we see most. The shape, structure, raw materials, or model names entered in the notification clash with the manufacturer's specifications or supporting documents. The product is not the problem — the documents are telling different stories — which feels unfair, but the reviewer has nothing to check against except the documents. The common origin is a reversed sequence: draft the notification first and receive the manufacturer's documents later, and you have created the conditions for the two to diverge. It is especially frequent on import projects, where an overseas manufacturer supplies documents in different templates and different notation.

3. Intended use beyond the item definition — the pattern ambition creates. The scope of the intended use you notify is the scope you may legally advertise — a point covered in the first instalment of this series. Hence the temptation to write the intended use as broadly as possible; but entering wording that leaves the item definition is itself grounds for a deficiency notice. The intended-use field is not a place for marketing copy — it is the place you align with the item definition. Expanding your advertising expression is a problem to solve after acceptance, inside the permitted scope.

4. Missing prerequisites — the pattern sequence creates. You prepare only the item notification, and learn at the filing stage that the import business licence and the quality manager designation come first. Since this pattern bounces the filing regardless of document quality, purely on sequence, it is the easiest of the five to prevent — one look at the overall order of the procedure before you start is enough. The full picture of the procedure for each class is in the procedure overview by class.

5. Missing or malformed attachments — minor-looking, but it eats time. A required document is missing, or a supporting document fails the required form or requirements. The fix itself is simple, but the calendar keeps running while deficiency notices and resubmissions go back and forth. Ten minutes cross-checking the attachment list item by item before submission is the whole of the prevention for this pattern.

You have been rejected — what comes first?

A rejection is not a penalty; it is rework. Rather than panicking and reaching for the notification form, work in the following order — it reduces the number of round trips.

Step 1 — Read the stated reason literally and identify the pattern. A classification problem, an inconsistent entry, and a document problem call for entirely different responses. If the wording of the reason reads ambiguously, asking the department in charge is faster than fixing by guesswork.

Step 2 — Realign the underlying documents first, not the notification form. Especially for pattern 2, decide first whether the notification should be corrected to match the documents, or the documents to match the notification. The yardstick is always the product as it actually is — align everything else to whichever document reflects it accurately.

Step 3 — Judge the scope of the rework. For entry or attachment problems, correcting the relevant part and resubmitting ends it. If a misclassification has confirmed Class 2, you have to switch tracks to the certification procedure — and at that point it is realistic to rebuild the schedule and the budget from zero.

Step 4 — Before resubmitting, check that the same root cause is not about to repeat. Fix only the flagged item and refile, and another item grown from the same root sometimes comes back as the next deficiency notice. Once a filing has been rejected, re-checking the whole document set for consistency — not just the flagged items — turns out to be the faster route.

What to check before submission

Invert the five patterns and you have your pre-submission checklist.

• Classification basis — do you hold the basis for the item name and class, and are there no class-raising factors such as sterile supply or a measuring function?
• Consistency — have you cross-checked shape, structure, raw materials, and model names in the notification against the manufacturer's documents, item by item?
• Intended use — is it written inside the item definition, with no advertising ambition mixed in?
• Prerequisites — for an import project, are the import business licence and the quality manager designation complete?
• Attachment list — have you checked the required documents against a list?

Of these, the classification basis and consistency are the two items a first-time filer finds hardest to be confident about. Rather than starting the paperwork without that confidence, sending the file for a pre-review exactly as it stands saves time whichever route you then take. The criteria for choosing between doing it yourself and using an agency are in the previous instalment; other questions on cost and timeline are answered on the regulatory consulting services page.

What CLARE Partners does

CLARE Partners is structured to step in before a rejection, not after one.

• Free pre-review — send your product information and existing documents, and we reply within one business day with a first assessment of the class, the required procedure, and the state of your documents. This is the step that checks the classification-basis and consistency items on the list above before you file
• Class 1 notification service — from preparing the submission documents to filing the notification, from ₩2.0M (the statutory fee of KRW 85,000 is itemized separately). One round of deficiency response is included in the base fee
• Taking over a case in progress — for a filing rejected mid-way, we confirm the stage reached and quote only the remaining work. Documents already drafted are assessed for reusability first
• Labelling review — even if you file the notification yourself, the label alone can be reviewed separately, from ₩0.5M

The full per-item fee schedule and how quotations are structured are on the regulatory consulting services page.

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Most of the five rejection patterns are catchable before submission. Before you start on the paperwork, send your product information for a free pre-review and we will check the item classification and the state of your documents first — you are welcome to take the findings and proceed on your own.

The statutory fee is the amount in attached Table 10 of the Enforcement Rule of the Medical Devices Act (e-filing basis, amended 1 Jul 2026) and may change as the legislation is amended. Agency fees are CLARE Partners' confirmed rates, quoted as minimum ("from") amounts. The rejection and deficiency patterns in this article are a general classification drawn from practice, not a ranking based on any statistics.