What Begins After Approval — Reporting, Records, Recall and Re-evaluation on One Page

Key takeaway — The certificate is the start of obligations, not the end. Eight axes run after approval, and each has its own deadline and its own counter. Adverse events are reported immediately, foreign matter without delay, supply records and standard codes periodically. Tracking records, recall, re-evaluation, post-market surveillance and renewal each move on their own cycle. Miss one and the administrative disposition comes back item by item. Compiled in September 2026 directly from the Medical Devices Act.

Eight branches on one page

Axis	When	Basis
Adverse event reporting	Immediately on becoming aware	Act Article 31(1)
Foreign matter reporting	Without delay on discovery	Act Article 31-5(1)
Recall	Without delay on learning of the harm	Act Article 31(2)
Supply record reporting	On supply, as prescribed by Ordinance	Act Article 31-2
UDI system registration	Standard code and information, as prescribed	Act Article 31-3
Tracking records	Prepare, retain and submit	Act Article 30
Re-evaluation	Items selected and published by the MFDS	Act Article 9
Post-market surveillance	Four to seven years if imposed at approval	Act Article 8

Licence renewal runs separately on a five-year cycle (renewal guide).

1. Adverse events — "immediately"

The wording of Article 31(1) is "report immediately" — stronger than "without delay". The trigger is becoming aware that death or serious adverse effects on the human body have occurred, or may occur, during use of the device. The report must be accompanied by keeping a record.

Note the duty-holder. The provision says not "manufacturer" but "device handler". Under Article 2(3) that covers manufacturers, importers, repairers, distributors and lessors, along with medical institution founders and veterinary hospital founders. A company that only distributes carries this duty.

On receiving the report the Minister may have the head of the Korea Institute of Medical Device Safety Information analyse and evaluate the causal relationship with the device and report the result (second sentence of the same paragraph).

2. Recall — faithful performance is favoured by the text

Article 31(2) requires manufacturers, importers, repairers, distributors and lessors (the provision calls them "manufacturers and other operators"), on learning that a device harms or risks harming the human body through defective quality, to recall it or take the measures a recall requires without delay. In that case manufacturers and importers must prepare a recall plan and report it to the Minister in advance.

The following paragraphs show how far a recall reaches.

• Paragraph 3 — on receiving a recall plan the Minister may order it published
• Paragraph 4 — for devices judged to have caused, or to risk causing, death or serious adverse effects, the Minister must inform the founders of the medical institutions that used the device of the adverse effects and the recall plan
• Paragraph 5 — a medical institution founder so informed must tell patients treated with the device, by visit, post, telephone, email or fax, and must submit to the Minister material proving that the patients were informed
• Paragraph 6 — for a manufacturer or other operator who has faithfully carried out the recall or the required measures, the administrative disposition under Article 36 may be reduced or waived

Paragraph 6 matters in practice. Delaying a recall is worse, under the text, than carrying it out.

3. Foreign matter — "without delay"

Article 31-5 was inserted in 2018. It defines foreign matter as "a substance inside a device or in its container or packaging that is not a normally used raw material and that may cause harm in use or is unfit for use", and requires the device handler who finds it to report without delay.

The Minister must investigate how it entered and take necessary measures (paragraph 2), and where necessary to prevent harm to public health may publish the finding, the investigation result and the planned measures (paragraph 3).

4. Supply records and the UDI system — two different axes

Two provisions that are often conflated.

	Supply record reporting	UDI system registration
Basis	Act Article 31-2	Act Article 31-3
What	The record of whom you supplied	The device standard code and device information
Who	Manufacturers, importers, distributors, lessors	Manufacturers and other operators
To whom	The MFDS Minister (the Minister of Health and Welfare may request the data)	The integrated device information system

Article 31-3(3) requires the integrated device information management standards to be observed in registering and managing that information, and system operation may be entrusted to the integrated device information centre (Article 31-4). The working screens are covered in the UDI portal guide, and the Class 1 scope in the UDI and supply reporting guide.

5. Devices subject to tracking — records in two layers

Article 30 imposes record duties for devices subject to tracking management. What is distinctive is that the duty-holders come in two layers.

• Handlers (manufacturers, importers, distributors, lessors, repairers) — records of manufacture, sale including purchase, lease or repair
• Users (medical institution founders and the doctors, oriental medicine doctors and dentists working there) — records enabling the patient to be traced

Both layers must prepare and retain the records and submit them to the Minister as prescribed. The Minister may order additional material for verification, and handlers and users may not refuse without justification (paragraph 2).

Paragraph 3 goes further. From users wishing to take part in long-term follow-up, information on procedures and adverse events generated in use (the provision calls this "real-world information") may be collected, analysed and evaluated.

6. Re-evaluation — not a procedure you apply for

Article 9(1) provides that the Minister may re-evaluate devices for which the safety and effectiveness are considered to require review, and may order necessary measures based on the result.

It is not something a company files for; the MFDS selects the items and publishes them. Under Article 19 of the Enforcement Rule the Minister determines the items after deliberation by the Medical Device Committee and publishes on the MFDS website the items, the application period and the content of the material to be submitted. The manufacturer of a listed item files within that period, and after re-evaluation the Minister makes the draft result available for at least one month before publishing it.

7. Supervision — from inspection orders to use suspension

The last of the post-approval axes is supervision.

Provision	Content
Article 32	Reports and inspections — entry, inspection, questioning, sampling
Article 33	Inspection order — testing by a designated body where public health may be harmed
Article 34	Sales suspension, recall, disposal and publication orders
Article 35	Use suspension order — against medical and veterinary institution founders

Article 32 is also the target of the amendment bill pre-announced on 4 August 2026, which would add a document-submission order (amendment guide).

Common mistakes

• Treating adverse event reporting as "without delay" and reporting days later — the provision says immediately
• Reading the adverse event and foreign matter duties as belonging only to manufacturers and importers — the provision says device handlers
• Delaying a recall and enlarging the sanction — a reduction provision for faithful performance exists (Article 31(6))
• Handling supply record reporting and UDI registration as the same thing — different provisions, different content
• Covering only the handler layer of tracking records and not the user layer at the medical institution
• Having nobody watching the MFDS website for re-evaluation notices — miss the application period and there is no way to respond

Pre-launch checklist

• Is an immediate adverse event reporting route in the company's procedures?
• Is there a separate foreign matter reporting procedure (a different provision from adverse events)?
• Are a recall plan template and the institution and patient notification steps prepared?
• Are the owner and cycle set separately for supply record reporting and UDI registration?
• Has it been confirmed whether your item is subject to tracking management? If so, is there a cooperation route with the institutions?
• Is there a cycle for checking the MFDS website for re-evaluation notices?
• Does the certificate state a post-market surveillance period?
• Is the renewal window (270 to 180 days before expiry) in the register?

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Post-approval duties are hard for one person to hold together. The deadlines split into immediate, without delay and periodic, and the counters differ. How many axes actually apply to your item, and which of them is currently empty, is what we check first in a free preliminary review.