Korea's Medical Devices Act Amendment Bill — Document-Submission Orders and a General Corrective Order (Comments Due 14 September)

Key takeaway — This bill does not change approval requirements. It writes the tools of administrative investigation and correction into the statute. Three points. ① The MFDS and local governments gain an express power under Article 32 to order handlers to submit documents. ② Article 35-2 (Corrective Order), so far used only for expenditure-report breaches, becomes a general provision covering any violation of the Act or of an order under it, with a duty to report compliance. ③ Refusing a report or a document submission becomes both a ground for administrative disposition and an offence punishable by a fine of up to KRW 5 million. Comments close on 14 September 2026. Compiled on 8 September 2026 from the public notice, the old-and-new text comparison table and the current provisions.

Timeline

• 4 August 2026 — Pre-announcement of the Medical Devices Act Partial Amendment Bill, MFDS Public Notice No. 2026-376
• 14 September 2026 — Comment deadline. Online through the integrated legislative notice system (opinion.lawmaking.go.kr) or in writing to the MFDS Medical Device Policy Division
• Thereafter — Ministry of Government Legislation review, Cabinet, submission to and passage by the National Assembly, promulgation. Because this amends a statute, it goes through the National Assembly, unlike a notification amendment
• Entry into force — Draft addendum Article 1: on the date of promulgation. Exception: the part of Article 36(1)21-2 relating to Article 35-2(1)3 follows the commencement of the corresponding provision of Act No. 21263

What follows is based on the pre-announced draft. Wording can change during parliamentary review, so re-check once the enacted text is promulgated.

What changes

1. Article 32 — "may order the submission of documents"

Current Article 32(1) (Reports and Inspections) lets the Minister of Health and Welfare, the Minister of Food and Drug Safety and heads of local governments require necessary reports from handlers and from technical-file review bodies, clinical trial institutions, non-clinical test facilities, quality-system audit bodies and sales-promotion agents, and lets them have public officials enter, inspect, question and collect samples.

The bill inserts one clause. Before "public officials", the text will read "may order the submission of documents, and". That creates a basis for demanding paperwork without a site visit.

The stated reason: to "specify that handlers may be required to submit necessary documents in addition to reporting to public officials and to entry, inspection and questioning." The regulatory impact assessment states the objective as "clearly defining the scope of powers relating to reports and inspections, thereby clarifying the procedure and scope of administrative investigation."

2. Article 35-2 — the corrective order becomes a general provision

Current Article 35-2 (Corrective Order) is narrow. Only the Minister of Health and Welfare may order manufacturers, importers, distributors, lessors and sales-promotion agents to correct a failure to prepare or publish the expenditure report under Article 13-2, or to retain its supporting records or the outsourcing contract (fully amended 8 August 2023).

Everything else has been handled through individual measure provisions — the inspection order (Article 33), the sales-suspension, recall, disposal and publication orders (Article 34) and the use-suspension order (Article 35). The stated reason describes exactly this: correction of unlawful states has been ordered "on the basis of necessary measures such as sales suspension, recall and disposal", and the legal basis for such corrective orders is to be made clearer.

The bill keeps the current text as paragraph (1) and adds two paragraphs.

Para.	Content
(2)	The Minister of Food and Drug Safety or the head of a local government may, where a handler has violated this Act or an order under this Act, set a period and order the violation to be corrected
(3)	A person who has complied with a corrective order shall report that fact without delay to the Minister of Food and Drug Safety or the head of the local government

Two things are new in practice. First, the issuing authority widens from the Minister of Health and Welfare to the MFDS and local governments, and the trigger widens to "any violation of this Act". Second, a duty to report compliance. Correcting the problem without reporting leaves a breach standing.

3. Sanctions — Articles 36 and 54 are amended together

Provision	Current	Bill
Article 36(1)19 (grounds for disposition)	Refusing, obstructing or evading entry, inspection, questioning or sampling by public officials under Article 32(1)	Refusing, obstructing or evading a report, a document submission, entry, inspection, questioning or sampling under Article 32(1)
Article 36(1)21-2 (as amended by Act No. 21263)	Failing to comply with a corrective order in breach of Article 35-2 subparagraph 3	Failing to comply with a corrective order in breach of Article 35-2 (1)3 or (2)
Article 54(2) (penalty — fine up to KRW 5 million)	Refusing, obstructing or evading entry, sampling, closure or other disposition by public officials under Article 32(1) or Article 36(1) and (2)	"a report, a document submission," inserted

Article 36(1) is the provision under which approvals, certifications and notifications can be revoked, premises closed, manufacture, import or sale of an item prohibited, and business suspended for up to one year. Placing refusal of a report or a document submission here means that not producing documents becomes a ground that can lead to business suspension.

Item 21-2 needs a word of explanation. The current Article 36(1)21-2 concerns the insurance obligation under Article 43-6. Act No. 21263 of 30 December 2025 rewrote that item to cover non-compliance with a corrective order, and that rewrite is awaiting commencement. The present bill extends the cross-reference to the new paragraph (2) (the general corrective order) and aligns its commencement with Act No. 21263.

4. Addenda — the corrective order reaches earlier violations

Draft addendum Article 2 (Application of corrective orders) states that the amended Article 35-2(2) also applies where correction is ordered in respect of a violation committed before this Act enters into force. A corrective order can therefore be issued not only for violations committed after commencement but also for a state of violation that already exists.

Who is covered

Under Article 2(3) of the Medical Devices Act, medical device handlers are:

• Device manufacturers, importers, repairers, distributors and lessors
• Medical institution founders under the Medical Service Act and veterinary hospital founders under the Veterinarians Act

Article 32 adds technical-file review bodies, clinical trial institutions, non-clinical test facilities, quality-system audit bodies, sales-promotion agents and the entrusted bodies under Article 15-2(2). The regulatory impact assessment counts 138,829 regulated entities (source: MFDS device information portal).

The number tells you this is not a large-manufacturer issue. An online seller who has filed a distributor notification for Class 1 products, a device lessor and a repair shop all sit under the same provision.

In practice

• Be in a position to answer a document-submission order at once. Approval, certification or notification certificates, the technical file, quality records, sales and lease records under Article 30, supply-record reports and advertising material are the documents likely to be requested. If locating them takes days, that is the gap to close.
• Set a corrective-order procedure in advance. Check the period in the order → correct → file the compliance report. The reporting step is the new obligation.
• A self-audit of past violations now has a purpose. Because of the application clause, pre-commencement violations are within reach of a corrective order. Start with the items that commonly linger — labelling, a missed renewal, an unfiled change approval, advertising beyond the approved scope.
• Check the cooperation clause in contracts with overseas manufacturers. An importer served with a submission order often needs the manufacturer's documents to meet the deadline.
• This is not yet enacted law, so no procedure needs to change today. The four points above are, however, the baseline state that the procedure overview already assumes, amendment or not.

Check now

• Is the company a handler under Article 2(3) or a body listed in Article 32? (Most are)
• Is there a list of documents, with storage locations, that can be produced within three business days of a request?
• Is it settled who handles a corrective order, on what report form, and how the deadline is tracked?
• Is a self-audit of pre-commencement items (labelling, renewal, change approval, advertising) scheduled?
• If you intend to comment, file before 14 September through the integrated legislative notice system or with the MFDS Medical Device Policy Division (043-719-3758)

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The weight of this bill lies not in the number of provisions but in the breadth of who it reaches. Most of the 138,829 entities have no dedicated regulatory staff. What to produce, in what order, when a submission order or a corrective order arrives — and whether the company's current records would hold up — is something we check first in a free preliminary review.