Electronic Submission and Application Process: Key Operational Points

1. Key takeaways

Korean item licences, item certifications and item notifications are filed through the e-government system, under the procedure set by MFDS Public Notice No. 2022-52 (effective July 29, 2022), which contains a deficiency procedure and a by-stage review mechanism. The full process runs in 5 steps: submission, acceptance, deficiency, review, and issuance.

• The statutory review periods are 5 working days for Class 1, 25 working days for a first Class 2 application, 55 working days for Classes 3 and 4 without a clinical trial, and 70 working days with a clinical trial.
• Outside the formal process there is one advance tool: the review of whether medical device regulation applies, with results notified in principle within 10 days. GRZAN uses it as a confirmation step before dossier preparation, not as a remedy after a dispute. Among the 5 steps, what truly decides the project timeline is the deficiency step, not the review.

2. Legal basis

The instruments below fix the filing procedure, the deficiency and by-stage mechanisms, and the statutory review periods. Regulatory information verified as of October 29, 2026.

Operational points of the 5 steps. The table lists the key action, the timing control and the common mistake at each step.

The specific stage division of the by-stage review and the items it applies to must follow the text of MFDS Public Notice No. 2022-52 (practical estimate).

3. Expert insights

The regulatory applicability review is an advance confirmation tool; use its 10-day reply before dossier preparation. The review of whether medical device regulation applies notifies its result in principle within 10 days, answering whether the product is a medical device and under which act it falls. GRZAN places it before dossier preparation: only after the answer arrives is the choice made as to which structure the Technical Document follows. Using it as a remedy after a dispute amounts to spending the documentation cost first and asking the question afterwards. Where the reply differs from the intended pathway, adjust before preparing the dossier, not after filing. The applicability determination method is in Article 03: Medical device definition and scope determination.

The by-stage review allows batched submission, but a wrong order sends the project backwards. MFDS Public Notice No. 2022-52 sets a by-stage review mechanism that lets the review proceed stage by stage. The mechanism buys rhythm flexibility and carries sequence risk: submitting later-stage materials before the earlier stage’s conclusion is fixed causes rework. GRZAN arranges the batches on the order of technical content first, supplementary evidence second, and checks the previous stage’s conclusion before every batch is filed.

Deficiencies reset the rhythm; the one-pass acceptance rate is the real timeline variable. Statutory review periods run in working days and exclude deficiency time. In Korean projects GRZAN tracks deficiency rounds, not review days, as the primary progress metric: the former is controllable, the latter is not. Deficiency rounds are traceable, and companies can adjust their dossier preparation standards backwards from them; the more rounds, the further the actual project timeline drifts from the statutory period. Treating the statutory period as the total project timeline is the main source of scheduling error; the method for stacking timelines is in Article 40: Timeline and budget planning.

The submitting party is the licence holder, and three duties start counting on the day of issuance. The application and filing of an import item licence must be initiated by the licence holder (practical estimate: the specific scope of authorization follows the licence holder authorization documents). A foreign manufacturer cannot hold an import item licence in its own name, see Article 31: The Korean licence holder (KLH) system. This division of roles determines the document flow at the electronic filing step: the Chinese manufacturer supplies the technical and quality materials, and the licence holder completes the filing and the subsequent responses.

Issuance is not the end. The medical device standard code data must be uploaded once the item information is obtained, and the database must be modified within 10 days of any information change; the item update runs every 5 years from October 8, 2020; and distribution record reporting applies in phases by class. The merged management of these three timelines is in Article 50: Korean post-market compliance calendar.

4. Practical recommendations

• Run the regulatory applicability review before preparing the dossier. Use the 10-day reply mechanism to move the applicability conclusion forward, avoiding a wasted and rewritten dossier.
• Check version consistency before submission. The Technical Document, the labeling texts and the UDI data must all be the same version; submitting across versions is a leading cause of deficiencies.
• Manage deficiency responses by internal deadline. Respond to all items of a deficiency notice in one pass; batching adds rounds, and batched responses may also restart the clock from the last batch (as stated in the deficiency notice governs).
• Track the statutory period by class. 5 working days for Class 1, 25 working days for Class 2, 55 or 70 working days for Classes 3/4, always on the working-day basis and never mixed with calendar days.
• Start the duty list on the day of issuance. Mount three tasks the same day – UDI data upload, the item update due date, and the distribution record reporting start date – and share the list with the licence holder so information does not stay on the Chinese manufacturer side only.

5. Verification checklist

• □ Regulatory applicability review: check whether the application was filed before dossier preparation; result obtained and consistent with the intended pathway.
• □ Submitting party: check the licence holder and authorization documents; filing initiated from the licence holder account.
• □ Version consistency: compare the Technical Document, labeling texts and UDI data; all three at the same version.
• □ Item group scope: check the applied models against the item group; all models fall within the item group scope.
• □ Statutory period basis: check Annex 1 by class; working-day basis used, not mixed with calendar days.
• □ By-stage order: check the submission batches of each stage; the next batch filed only after the previous stage’s conclusion is fixed.
• □ Deficiency response: check the deficiency response records; all items answered in one pass, rounds traceable.
• □ Post-issuance duties: check that the duty list is mounted; UDI data, item update due date and distribution record reporting start date all registered.

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 prepares MFDS-compliant technical dossiers, coordinates KGMP documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com