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What Should You Know About Import Notification of Medical Devices in South Korea? What Information Needs to Be Filled In?

Time：2026-08-14 11:20:37

Many foreign trade practitioners exporting medical devices to South Korea simply refer to this Korean official document as a "Korea registration certificate". Strictly speaking, however, it is neither an approval license nor a certification certificate. This document is the Import Notification Certificate for Medical Devices (의료기기 수입 신고증), exclusive to Class I medical devices in South Korea.

一、Identify the Certificate Title

의료기기 수입 신고증 = Import Notification Certificate for Medical Devices

Once you spot the term 신고증 (Notification Certificate) on the header, you can immediately confirm this is an import notification receipt issued by NIDS (National Institute of Medical Device Safety Information) for Class I devices.

Three Core Regulatory Documents for Korean Medical Devices (Clear Distinction):

신고증 Notification Certificate (Class I Devices)：Issued & processed by NIDS under a post-fact notification system. No substantive technical review by regulators; enterprises only need to submit documents to complete notification and obtain the certificate.

인증서 Certification Certificate (Class II Devices)：Issued by designated Third-Party Assessment bodies (TPAs) such as KTL. Mandatory technical dossier review plus quality system audit required.

허가서 Approval License (Class III & IV Devices)：Directly issued by MFDS (Ministry of Food and Drug Safety). Undergoes rigorous full technical review for high-risk devices.

Key Reminder：Class I Notification ≠ Registration Approval.Class I devices carry minimal risk, so Korean regulations adopt a notification system rather than a pre-market approval system. While this notification certificate serves as legal proof of market access, its legal validity and review mechanism differ drastically from Class II–IV documents. They cannot be used interchangeably or falsely presented as approval licenses.

二、Line-by-Line Breakdown of Key Fields on the Notification Certificate

（一）Top Selection Panel

Import: Indicates the filing is submitted by a local Korean importer, not an in-country manufacturer.
Single Item: Notification covers one specific model only. If marked "Product Category", the filing covers a series of related models.

Practical Tip：Single-item notification locks one model onto the certificate. Category notification allows adding new models within the registered scope without re-filing, which is the preferred option for most manufacturers.

（二）명칭（Product Name, Model & Classification Code Section）

분류번호(등급)：Classification Code (Risk Class) – this field will clearly state 1등급 (Class I).。

Every medical device in South Korea has an official classification code, and the final digit of the code denotes its risk class. Common Pitfall: Many clients only check the product name and ignore the risk classification code. Customs will detain shipments if you attempt to clear Class II goods using a Class I notification certificate.

（三）제조(수입)업자 정보 Manufacturer & Importer Information Block

수입업자 (Importer): Licensed local Korean entity that bears full regulatory liability. All medical devices imported to South Korea must be filed under a local Korean importer; overseas manufacturers cannot act as the filing subject directly.
제조원 (Manufacturer): Details of the overseas production factory.

Regulatory Knowledge Snippet: To submit Class I import notifications, the local importer must hold a valid Medical Device Import Business License (업 허가번호, located at the top right of the certificate). No import filing can proceed without this license number, which is printed as the business permit ID on the certificate header.

（四）신고조건 Filing Type Identifier

This field is fixed as 신고 (Notification) to mark the document category.

Quick Comparison Table:

Class I Notification: 신고
Class II Certification: 인증
Class III/IV Approval: 수허

（五）유효기간 Validity Term

Class I notification certificates have no mandatory expiry date. The date printed on the document refers only to the registration record validity date. The notification remains effective indefinitely as long as there are no changes to product models, importer details, or manufacturing factory information. Any updates to these details require a modification notification filing.

Frequently Asked Question from Domestic Manufacturers: "How many years is the certificate valid?" Answer: Class I notifications do not auto-expire. Updates are only required when core product or corporate information changes — a critical difference from Class II/III/IV certificates, which carry fixed validity periods.

（六）Legal Basis at the Bottom

Issued under Articles 6 and 15 of the Medical Device Act and its implementing ordinances. Issuing Authority: National Institute of Medical Device Safety Information (NIDS)

Important Distinction：NIDS≠MFDS。 MFDS is the top government regulatory authority for food, drugs and medical devices. NIDS is an affiliated executive agency under MFDS exclusively responsible for Class I device notification acceptance. Class II reviews are handled by third-party TPAs, while Class III/IV approvals are directly issued by MFDS headquarters.

三、Top 4 Common Compliance Pitfalls for Exporters

Misconception 1：Class I 신고증 = Official Korea Registration Certificate

Correction: This is merely a notification receipt with no government technical review. Only Class II–IV documents are formal approval/certification documents. Many tender projects explicitly reject notification certificates and require formal certification or approval licenses for bidding eligibility.

Misconception 2：Notification certificates are permanent; no updates needed for changed information

Correction: Any modification to product models, production facilities or importers mandates a modification filing. The original notification becomes invalid without updates, and marketing the device without updated documentation constitutes illegal market access.

Misconception 3：Class I filing is simple — any Korean company can act as importer

Correction: Korean importers bear full post-market regulatory obligations, including adverse event reporting and product recalls, and must hold a valid import business license. Careful selection of a qualified local importer is essential.

Misconception 4：Certificates look identical, so Class I/II/III documents can be swapped

Correction: Regulators and Korean Customs cross-verify three matching criteria: document header, serial number prefix, and issuing body against the product risk class via the MDIS database. Mismatches result in cargo detention and compliance penalties.

四、Closing Remarks

Most Chinese exporters confuse South Korea’s tiered medical device registration framework. The three independent systems — Class I Notification, Class II Third-Party Certification, and Class III/IV Government Approval — cannot substitute for one another.When you receive a Korean medical device document, first check the core Korean keyword on the header to instantly identify its document type and avoid costly customs clearance or tender compliance risks. For further inquiries on Korea medical device regulatory compliance, feel free to contact Wiselink.

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