Class 1 Item Notification in South Korea: Timeline, Fees and Obligations

1. Key takeaways

Class 1 devices go through item notification, submitted to the National Institute of Medical Device Safety Information (NIDS), with a statutory review period of 5 working days and an official fee of KRW 85,000. Notification is exempt from submitting technical documents and clinical data, making it the pathway with the lightest documentation burden of the three.

The scope of the exemption must be stated precisely: KGMP is mandatory for Class 2 to Class 4 and does not apply mandatorily to Class 1, so a Class 1 notification does not need a KGMP certificate as a precondition. But this exemption covers only the quality system audit; it does not cover entity qualification or post-market obligations. A foreign manufacturer must still submit its import item notification through a licence holder that has a business presence in Korea and a full-time quality manager; after market entry it must still fulfill unique device identifier (UDI) assignment and data submission (applicable to Class 1 from 1 July 2022), distribution record reporting (applicable to Class 1 from 1 July 2023), and item renewal every 5 years from 8 October 2020.

GRZAN summarizes Class 1 notification as “lightest at the entry, not light at the tail”: the upfront investment is low, but none of the post-market obligations is reduced.

2. Legal basis

The notification route and the surviving obligations rest on the following instruments.

Timeline of obligations applicable to Class 1 devices (under the Medical Device Act and subordinate decrees)

3. Expert insights

Exemption from technical documents is not exemption from documents. Although item notification is free of technical documents and clinical data, basic information such as the item name, models, the manufacturing or importer information, and the classification and class conclusion must still be complete, and must be submitted in Korean. Most Class 1 notification rejections GRZAN has encountered were not caused by insufficient technical depth, but by inconsistent wording between the item name and the classification rules, or inconsistency between the notifying entity and the business licence record. These problems are stopped at the formality check stage, and the advantage of the 5 working days period is lost immediately.

The boundary of the KGMP exemption is the class, not the pathway. KGMP is mandatory for Classes 2-4 and exempt for Class 1, judged by class rather than by whether the product is imported. If the same foreign manufacturer exports both Class 1 and Class 2 products, the Class 2 items still require a completed KGMP conformity audit before item certification, while Class 1 does not. GRZAN advises companies not to infer that an entire product line is exempt from KGMP because one Class 1 item “went through”: once the class changes, the conclusion changes.

Five working days is a post-acceptance period, not a project timeline. 5 working days converts to roughly one week in calendar terms, but it covers only the processing period after acceptance. For imports, selection of the licence holder and configuration of the import business licence, fixing the Korean item name, and preparing UDI data all happen before acceptance. GRZAN places the schedule control point of Class 1 projects before acceptance, not after it.

Post-market obligations run at the same intensity as for higher classes. Class 1 devices must likewise complete item renewal every 5 years under Article 49 of the Medical Device Act, complete UDI assignment and submit data to IMDIS from 1 July 2022, and fulfill distribution record reporting from 1 July 2023. A lighter documentation burden upfront does not license simplified post-market management. GRZAN assigns Class 1 clients the same compliance calendar template used for every other class.

4. Practical recommendations

• Confirm the business licence before submitting the item notification. For imports, the licence holder’s import business licence is a precondition; an unsettled entity qualification makes the notification impossible to accept.
• Align the item name with the wording of the classification rules. Inconsistency between the name and the rules is the most common rejection cause for Class 1 notifications; compare the name word by word against the rules before submission.
• Start UDI data preparation together with the notification. UDI assignment applies to Class 1 from 1 July 2022; starting it only after the notification is complete pushes the market-entry date back.
• Do not extrapolate Class 1 experience to other classes. Whether KGMP applies and whether technical documents are required are both judged by class; confirm each class on its own.
• Put item renewal into a long-term register. Renewal every 5 years from 8 October 2020 applies equally to Class 1 and Classes 2-4; manage it together with other deadlines.

5. Verification checklist

• □ Class confirmation — cross-check against Annex 1 of the Enforcement Rule; standard: clearly Class 1 with no cross-class dispute.
• □ Notifying entity — verify the business licence and licence holder qualification; standard: a valid manufacturing or import business licence, and the entity matches the notification.
• □ Item name — compare against the classification rules and the name wording; standard: the Korean name is consistent with the classification rules.
• □ Document scope — check against MFDS Public Notice No. 2022-52; standard: free of technical documents and clinical data, with basic information complete.
• □ KGMP applicability — judged by class; standard: Class 1 is not within the mandatory KGMP scope.
• □ UDI and distribution records — check the Class 1 start dates; standard: the two obligations of 1 July 2022 and 1 July 2023 are both configured.
• □ Item renewal — check the certificate date and renewal cycle; standard: the 5-year renewal node is entered in the register.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team manages MFDS approvals, certifications and notifications, prepares equivalence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com