Exemption from Post-Market Surveillance for Rare Devices — The Enforcement Rule of 1 July and the Draft Notification

Key takeaway — Post-market surveillance is not a moment at approval but an obligation that binds four to seven years after it. It applies to newly developed and rare medical devices, and brings with it an approved surveillance plan and periodic reporting. An amendment to the Enforcement Rule, in force since 1 July 2026, created the basis for exemption, and on 6 August the MFDS pre-announced a notification amendment filling in what that rule delegated (Public Notice No. 2026-393). Comments closed on 26 August, so what matters now is when the final notification is issued and what to prepare in order to claim exemption. Compiled on 8 September 2026 from the public notice, the old-and-new comparison table and the current legislation.

Timeline

• 1 July 2026 — Amended Enforcement Rule of the Medical Devices Act takes effect, creating the basis for exempting rare and other devices from post-market surveillance
• 6 August 2026 — MFDS Public Notice No. 2026-393 pre-announces a partial amendment to the Regulation on Post-Market Surveillance of Medical Devices (Notification No. 2023-53)
• 26 August 2026 — Comment deadline
• 30 August 2026 — MFDS press reference "Criteria established for exempting rare devices from post-market surveillance"
• Final notification — The draft addendum provides for entry into force on the date of issuance. As checked on 8 September 2026, publication of the final notification was not confirmed

1. What post-market surveillance is

Article 8 of the Medical Devices Act is titled "Post-Market Surveillance of Newly Developed Medical Devices, etc." When granting a manufacturing approval (including a change approval), the MFDS Minister may require the manufacturer to conduct surveillance of safety and effectiveness for a period, set by the Minister within a range of four to seven years after the item is marketed.

There are three categories (Article 8(1)).

No.	Category
1	Newly developed device — at least one of the principle of action, the type or quantity of raw materials (body-contact devices only), the method of use including procedure and site, or the performance or intended use is entirely new compared with an approved, certified or notified item
2	Rare device — designated by the Minister as having few patients with the target disease domestically and special value in use
3	A device equivalent to a newly developed device under subparagraph 1 whose surveillance is not yet complete

The period is written on the manufacturing approval certificate (Enforcement Rule Article 18(1)). The manufacturer must prepare a surveillance plan and obtain the Minister's approval (Act Article 8(3)), and must report periodically on the data collected and the conduct of the surveillance (Article 8(4)). If the review of those reports shows a serious risk to public health, the Minister may order the plan to be changed even during the surveillance, or revoke the approval after committee deliberation (Article 8(5)).

The obligation outlives the surveillance. Under Article 8-2, within three months of the end of the period the manufacturer must submit usage-result data and adverse event cases for review, and must retain that data and the adverse event records for two years from submission.

2. The exemption basis created on 1 July

Article 18(2) of the Enforcement Rule, giving effect to the proviso to Article 8(1) of the Act, allows the Minister to exempt a device from post-market surveillance after deliberation by the Medical Device Committee in two cases.

1. A newly developed device falling in Class 1 or Class 2
2. A device approved in a foreign country that the Minister recognises as operating medical device safety management at a level equal to or above Korea's, with overseas usage experience meeting criteria published by the Minister, being either
   • a newly developed device, or
   • a rare device

In the second route, "criteria published by the Minister" was empty. That is the gap this draft notification fills.

3. What the draft adds — a new Article 9 (Exemption)

The pre-announced draft inserts Article 9 (Exemption) into the Regulation on Post-Market Surveillance of Medical Devices and shifts existing Articles 9 to 11 to Articles 10 to 12.

Paragraph 1 — defining "a device with overseas usage experience"

The Enforcement Rule's phrase is defined as a device whose safety and effectiveness are sufficiently established when matters of usage experience, including overseas post-market clinical experience, safety information and approval and sales status, are considered as a whole.

Paragraph 2 — two sets of material

An applicant for exemption must submit the following to the Minister as evidence of overseas usage experience.

No.	Material
1	Foreign material equivalent to the clinical trial data under Article 26(1)6 of the Regulation on Approval, Notification and Review of Medical Devices, or survey and analysis data on overseas post-market safety and effectiveness
2	Material corresponding to Article 6(1)2 and 3 of the same Regulation — overseas approval, sales and usage status data — and data analysing and evaluating collected overseas adverse event information

The stated reason is to "clarify the exemption matters delegated to subordinate legislation and thereby improve the predictability of applications." Until now, an applicant seeking exemption had no published list of what to file.

4. In practice

• Design the exemption request into the approval stage. Surveillance is imposed when the approval is granted, so contesting whether the exemption requirements are met during the review is more natural than arguing it after the obligation has been imposed.
• Overseas data must be analysed, not merely held. Subparagraph 2 asks for data analysing and evaluating collected overseas adverse event information. Passing on the manufacturer's raw files is not enough. This is another reason a cooperation clause belongs in the manufacturing agreement.
• Which country granted the approval is the fork. "A foreign country the Minister recognises as operating safety management at a level equal to or above Korea's" is the precondition, and the scope of that recognition is not for the company to decide. Confirm it in advance.
• Class 1 and 2 newly developed devices take the other route, independent of overseas usage experience, under Article 18(2)1.
• If exemption is not available, put four to seven years into the plan. Plan approval, periodic reporting, submission within three months of the end, and two years of retention are one package, running on an axis separate from licence renewal.

5. Do not confuse this with new health technology assessment

The names sit close together but the layers differ.

	Post-market surveillance	New health technology assessment
Basis	Medical Devices Act Article 8	Medical Service Act Article 53
Authority	Ministry of Food and Drug Safety	Ministry of Health and Welfare
What is examined	Post-market safety and effectiveness of the approved product	Safety and effectiveness of the medical technology using it
When	After approval, four to seven years	Around the market-entry stage

Some products meet both. See the new health technology assessment guide.

Check now

• Has it been assessed whether the product is a newly developed device, a rare device or an equivalent device?
• Does the approval certificate state a surveillance period? If so, confirm the status of the plan approval
• If seeking exemption, is the route identified — Class 1/2, or overseas usage experience?
• For the overseas route, is the country within the Minister's recognised scope?
• Can the manufacturer supply overseas approval, sales and usage data and the adverse event analysis?
• Is someone assigned to watch for publication of the final notification?

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Post-market surveillance is hard to undo once imposed, and exemption is best argued at the approval stage. Whether your product is in scope, and whether your overseas data meets the exemption requirements, is what we check first in a free preliminary review.