Legal Hierarchy of Korean Medical Device Regulations: Four Layers of Law

1. Key takeaways

The legal force of Korean medical device regulation flows from 4 layers: the Act enacted by the National Assembly (the Medical Device Act), the Enforcement Decree issued in the form of a Presidential Decree, the Enforcement Rule issued in the form of a Prime Ministerial Decree, and the MFDS Notifications issued by the Ministry of Food and Drug Safety (MFDS). The first three layers answer who has the authority, what obligations apply and which procedures govern; the fourth layer answers what the dossier should look like, how reviews are judged and how data are reported.

The most common error companies make when researching the regulations is to cite the act itself to answer technical questions. Taking the technical dossier as an example, the Medical Device Act only gives the statutory definition of the technical dossier and the obligation to submit it; the specific composition, review method, staged review and product group rules are written in MFDS Notification No. 2022-52 (effective 29 July 2022). A misaligned citation level will be met at the correction stage with a demand to redo whole sections.

Amendments of the four layers are not synchronised. Since the Medical Device Act was enacted and promulgated on 29 May 2003 and came into force on 30 May 2004, it has been amended many times; among these, Article 49 (item renewal) was amended by Act No. 17248 with effect from 8 October 2020. The Enforcement Decree currently in force is Presidential Decree No. 36445 (partially amended and promulgated 23 June 2026, effective 1 July 2026) and the Enforcement Rule currently in force is Prime Ministerial Decree No. 2127 (partially amended and promulgated 1 July 2026, effective the same day); both must still be checked provision by provision at the National Law Information Center. Notifications are numbered year by year in a year-sequence format. GRZAN advises recording the confirmation date of the current version of every layer document in the project file instead of reusing old numbers from historical templates.

2. Legal basis

The key instruments and their citation entry points are summarised below.

Form and search entry points of the four layers (supplementary table)

3. Expert insights

Insight 1: Technical requirements sit in the notifications, not in the act.

The role of the Medical Device Act is to grant authority and impose obligations; its articles do not state how many copies of a document or how many data fields are required. What GRZAN has encountered in projects is that when a company answered a review body’s correction request on the composition of the technical dossier by citing the act, the reply was to submit according to the current notification. Technical standards, review procedures and data fields are almost entirely concentrated at the notification layer; the act provides only the basis of the obligation.

Insight 2: The Enforcement Decree and Enforcement Rule carry the delegated provisions into effect.

Liability compensation insurance is a typical sample: the Medical Device Act was amended by Act No. 18319 with effect from 21 July 2022, establishing the obligation to insure; the parties covered and the insured amounts are specified in Articles 12-5 and 12-6 of the Enforcement Decree. Reading the act alone cannot determine whether your product falls within the scope of insurance; you must go down to the Enforcement Decree.

Insight 3: Unsynced amendments are the main source of obsolete versions.

Item renewal is a statutory obligation every 5 years (Article 49 of the Medical Device Act, effective 8 October 2020), yet the accompanying renewal document checklist is set by notification. Companies that track only act amendments and miss notification updates prepare documents against the old checklist and get returned at intake.

Insight 4: Notifications can also conflict in applicability; the special rule prevails.

Digital medical devices follow the subordinate notifications of the Digital Medical Products Act, in vitro diagnostic devices follow the subordinate notifications of the In Vitro Diagnostic Medical Devices Act, and ordinary devices follow notifications under the Medical Device Act system. Where a product straddles two categories, the attribution must be determined first before selecting the applicable set; parallel citation is not acceptable.

4. Practical recommendations

• Establish a four-layer cross-reference table as the baseline project document. At project start, list the matters involved with one row per layer, stating the current number and confirmation date, as the underlying basis for traceable conclusions.
• Write the notification number into the version note of document templates. The technical dossier, the KGMP self-check list and the UDI data sheet should state the notification number they rely on (for example MFDS Notification No. 2022-52), so that outdated templates are not reused unknowingly.
• Mark act amendments by effective date, not promulgation date. Act No. 17248 was promulgated on 7 April 2020 and took effect on 8 October 2020; scheduling by promulgation date starts unnecessary work early.
• Review the notification list at least quarterly. Notifications are numbered and issued by year; GRZAN advises a quarterly review of the current list and an impact assessment for certified products.
• Archive screenshots of search results from the National Law Information Center. Where the layer attribution is disputed, screenshots of the current version are the comparison basis, at a cost far below later rework.

5. Verification checklist

• □ Current version of the act layer: retrieve the current text of the Medical Device Act at the National Law Information Center; number, promulgation date and effective date all recorded.
• □ Versions of the Enforcement Decree and Enforcement Rule: check the texts of Presidential Decree No. 36445 and Prime Ministerial Decree No. 2127; the confirmation date of the current version noted, with decree number, promulgation date and effective date all recorded.
• □ Validity of notification numbers: check MFDS notifications against the year-sequence format; none superseded or repealed.
• □ Citation level alignment: check item by item that technical questions are answered from the notifications; all technical requirements sourced from the notification layer.
• □ Effective date versus promulgation date: compare the promulgation and effective dates of acts and notifications; schedules counted from the effective date.
• □ Special act applicability: determine whether the product is an IVD or a digital medical product; a single unambiguous attribution with no parallel citation.
• □ Amendment tracking mechanism: check the quarterly review records; documented and impact assessed.

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 manages MFDS premarket approvals and KGMP conformity, coordinates import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com