Medical Device Definition and Applicability Determination under Korean Law

1. Key takeaways

To determine whether a product falls under Korean medical device regulation, the starting point is the definition clause in Article 2 of the Medical Device Act: along the axis of the four intended purposes of diagnosis, treatment, prevention and alleviation, combined with whether the mechanism of action is primarily pharmacological, immunological or metabolic, the product is classified as a device or a non-device. The conclusion of this determination decides everything that follows. If applicability is judged wrongly, the grade, the route, the dossier and the timeline all start over.

The second step is to rule out the special acts. Since 1 May 2020, in vitro diagnostic devices have been governed separately by the In Vitro Diagnostic Medical Devices Act (enacted and promulgated as Act No. 16433 on 30 April 2019 and effective 1 May 2020; the current version is Act No. 21525, amended by another act on 7 April 2026 and effective 8 October 2026). Since 24 January 2025, digital medical devices, and since 24 January 2026, digital medical and health support devices, have been governed by the Digital Medical Products Act. The three acts each carry their own definitions and routes; there is no option of filing first under the Medical Device Act and then switching tracks.

The third step is confirmation of boundary products. Korea operates a formal reply mechanism for the review of whether the medical device regulation applies. A company may apply for an official determination of whether its product is a medical device, with the reply period managed as 10 days (a practical estimate; the processing period stated by the competent authority at acceptance prevails). GRZAN advises obtaining the reply before starting dossier preparation for boundary products.

2. Legal basis

The instruments defining applicability, and the three-step determination sequence, are set out below.

The three-step sequence of the applicability determination (supplementary table)

3. Expert insights

Insight 1: The order of determination is irreversible; applicability precedes classification.

What GRZAN has encountered in projects is a company that assigned its product to Class 2 by experience, finished the technical dossier, and only then discovered the product was an in vitro diagnostic device and had to switch to the route under the In Vitro Diagnostic Medical Devices Act, changing both the dossier structure and the review body. The applicability determination is process step zero and costs almost nothing; skipping it makes the rework cost equal to the entire technical dossier.

Insight 2: Mechanism of action is easier to overlook than intended use.

Beyond the four purposes, the determination must consider whether the product achieves its primary action through pharmacological, immunological or metabolic means; products acting primarily through these three means are not regulated as medical devices. GRZAN advises companies to enter both the intended use and the primary mechanism of action in the determination sheet, and to proceed to the next step only when the conclusions of the two columns agree.

Insight 3: Attribution of software and AI products can no longer follow old experience.

Since 24 January 2025, digital medical devices have been carved out of the Medical Device Act into separate legislation; since 24 January 2026, digital medical and health support devices have also been brought under the Digital Medical Products Act. GRZAN advises that projects newly started in 2026 treat the question of whether the product falls under the Digital Medical Products Act as an independent determination item, not as a sub-case of the Medical Device Act.

Insight 4: Boundary products should first lock the conclusion through the reply mechanism.

For products at the crossing points of cosmetics, health foods and health management with medical use, a slight change of wording in the labelling can swing the conclusion between device and non-device. Applying for an applicability review for such products yields a reply that serves both as the basis for internal decisions and as evidence for later communication with the licensed entity and distributors. The reply period is managed as 10 days (a practical estimate).

4. Practical recommendations

• Make the determination sheet a one-page documented record. List the product name, intended use, primary mechanism of action, governing act, decision maker and decision date. GRZAN requires this sheet from every Korean project at the start-up stage and keeps it in the project file.
• Judge combination products part by part. For device-drug and device-software combinations, determine the attribution of each constituent part separately and then fix the overall route by the combination rules, instead of issuing one blanket conclusion.
• Keep labelling wording consistent with the determination conclusion. Korean review compares the use statements in the labelling; a product determined to be a device that shows non-device use statements in its labelling will trigger a correction request.
• Apply first for the applicability reply for boundary products. Obtaining the reply before investing in dossier preparation moves the rework risk forward and dissolves it early.
• Review determined products once a year. The Digital Medical Products Act is being implemented in stages (24 January 2025 and 24 January 2026); the attribution of already determined products may change as the new act comes into force.

5. Verification checklist

• □ Intended use: check against the four purposes of Article 2 of the Medical Device Act; at least one purpose applies and is documented.
• □ Primary mechanism of action: determine whether pharmacological, immunological or metabolic means dominate; the conclusion is definite and not phrased as possible.
• □ Ruling out special acts: check against Article 2 of the In Vitro Diagnostic Medical Devices Act (Act No. 16433, current version Act No. 21525, effective 8 October 2026) and the scope of the Digital Medical Products Act; a single unambiguous attribution.
• □ Handling of boundary products: check whether an applicability review has been applied for; the acceptance receipt and the reply document are on file.
• □ Labelling consistency: compare the use statements in the labelling with the determination conclusion; no conflicting statements.
• □ Split of combination products: attribution determined for each constituent part; the split sheet is complete.
• □ Annual review of determinations: check the review record and date; reviewed within 12 months.

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