Regulation on the Permission, Notification, Review, Etc. of Medical Devices in South Korea (MFDS Public Notification No. 2022-52)

1. What this regulation is (and why it matters for conformity assessment)

This Public Notification sets out the detailed procedures and document requirements for manufacturing/import permission, certification, and notification, as well as review of technical documents, under the Medical Devices Act and its Enforcement Rule. Official status (Notice No. 2022-52; effective 29 July 2022): National Law Information Center (Korea) – Administrative Rule side info ([law.go.kr][1])

If you are using an English translation, note that translations published online are generally for reference only and not legally effective. For example, the KLRI e-Law service states that translations are for reference and not legally effective: KLRI e-Law – Medical Devices Act (ENG) ([elaw.klri.re.kr][2]) MFDS also publishes the regulation in English on its site for reference: MFDS – Regulations (Medical Devices) (English) ([law.go.kr][1])

Practical tip: this document has later amendments on the Korean legal database, so always confirm whether a newer version applies before filing. National Law Information Center – main entry ([law.go.kr][1])

2. Key definitions you’ll see in submissions

The regulation defines core terms used throughout filings, including:

• Product group (품목군) and how MFDS groups devices for administrative handling
• Disposable medical device and other defined device categories
• The meaning of manufacturing/import permission, certification, and notification within the filing system Cross-reference (Korean legal text): National Law Information Center – Regulation text (KOR) ([law.go.kr][1])

3. Choosing the correct pathway: permission vs certification vs notification

In practice, conformity assessment starts by determining:

1. whether the product is regulated as a “medical device,” and
2. which regulatory route applies (permission/certification/notification), which is typically tied to device class/risk and product category (as defined in MFDS classification frameworks referenced by the regulation).

When uncertain, the regulation provides a formal mechanism to request a determination:

• Review of applicability of medical device regulations: MFDS reviews the request and notifies the result (in principle) within 10 days.

4. Filing mechanics and common document expectations

4.1 How notifications are handled

For manufacturing/import notifications, the regulation describes submitting required materials through an electronic government service system, and explains how the authority processes and records the notification.

4.2 Devices packaged as a “set”

If multiple devices are packaged and supplied as a set, the regulation explains how to determine the applicable classification and what to submit for the set.

4.3 Raw materials with safety/efficacy concerns

Where a device uses raw materials that may raise safety or efficacy concerns, the regulation requires additional consideration and supporting evidence (and it references an attached list).

5. Technical document review: how MFDS evaluates conformity evidence

5.1 Review and supplementation workflow

The regulation describes how reviewing bodies can request supplementation, and how applicants should respond (including a structured process for receiving and addressing supplementation requests).

5.2 Staged (by-step) technical document review

A notable mechanism is by-stage review, where technical documentation can be reviewed in stages (e.g., stage-based submission/review), and the regulation addresses timelines and handling of results.

This can help teams de-risk conformity assessment by validating key evidence earlier (especially for complex devices or software-heavy products).

6. Managing change after approval/filing (a common compliance failure point)

6.1 Change control expectations

The regulation includes provisions on changes to the contents of permission/certification/notification, and how such changes should be handled in filings.

6.2 Software-related changes

The regulation explicitly covers medical device software and addresses the scope of allowable function improvements and related documentation expectations.

7. Special cases and compliance carve-outs

7.1 Exemptions from distribution business notification

The regulation lists scenarios where distribution-business notification obligations may not apply (e.g., certain low-risk products or categories, including specified items such as thermometers, blood pressure devices, and self-diagnostic medical mobile app categories, as listed).

7.2 Permission for exhibition purposes

It also provides a pathway for permission of medical devices for exhibition purposes, including conditions and how to apply.

7.3 Orphan medical devices (designation process)

The regulation includes an administrative process around designation of orphan devices and notification of results (and indicates MFDS may seek advice when necessary).

8. Practical conformity assessment checklist (based on the regulation)

1. Confirm applicability (is it a medical device? which class/product category?)

   • If unclear, use the 10-day applicability review request process.

2. Select the correct route: permission vs certification vs notification.

3. Prepare core technical documentation and plan for supplementation cycles.

4. Consider staged review for complex submissions.

5. Establish change control early—especially for software.

6. Check special-case pathways (exhibition, exemptions, orphan designation) if relevant.

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Primary reference (English copy hosted by MFDS): MFDS – Regulations (Medical Devices) (English) ([law.go.kr][1]) Korean legal text / amendments: National Law Information Center – Regulation entry ([law.go.kr][1])