Self-Regulatory Advertising Review for Medical Devices in South Korea

1. Key takeaways

South Korea operates a self-regulatory review system for medical device advertising: the heading of Article 25 of the Medical Devices Act is self-regulatory review of advertising (광고의 자율심의), the review is conducted by self-regulatory review institutions, and it is not a pre-review by the Minister of Food and Drug Safety. The rule has extremely broad coverage — whether printed materials, exhibition panels, internet pages or social media content, any expression of information intended to promote sales of the medical device should first pass self-regulatory review.

• The statutes do not set a processing period for self-regulatory review; each review institution determines its own. The law fixes three other periods: review result validity 3 years (Article 25(7)); re-review applications within 30 days (Article 25(4)); objections within 30 days (Article 25(5)). These are the only statutory figures to rely on; the review turnaround has no statutory ceiling.
• The Digital Medical Products Act creates an important branch: for digital medical device software designated professional-use (전문용), placement in professional media only is permitted, with a review exemption in that scope; such products may also be notified by the competent ministry to the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service as a consideration for health insurance listing. For software device companies this affects both the promotion channel and the gateway to reimbursement.
• One boundary: professional media placement and the exemption rest on a restricted placement scope; once the channel goes beyond professional media to mass media, the exemption falls away.

2. Legal basis

The following instruments define the review system, the statutory periods and the digital-health branch.

Note: the statutes do not set a processing period; each review institution determines its own. The designation scope of professional use, criteria for professional media and exemption conditions are matters for subordinate rules; per case, current notices and the competent authority’s replies govern.

3. Expert insights

Insight 1: the object of self-regulatory review is the expression, not only advertising in the traditional sense.

The easiest mistake in South Korea is to exclude official website product pages, exhibition panels, distributor signage and self-produced videos from advertising. The test is whether the material intends to promote sales, not what it is called. Run every outbound material through the review checklist at the concept stage rather than submitting the day before release.

Insight 2: the exemption for digital-health professional-use software is in essence a change of channel and rules.

Restricting the audience to professionals lowers the risk of misleading information and buys procedural simplification. The real homework is channel management — which media are professional media and which readerships are professionals need written judgements in advance, with the placement scope documented. The exemption is not an unconditional pass.

Insight 3: the insurance listing channel connects promotion with market access.

The possibility of notifying the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service for listing consideration means the commercial loop for this class of software devices does not end at review but continues into health insurance listing. Where the target market includes the Korean payment side, GRZAN judges that promotion strategy and reimbursement rhythm should be designed together, not marketing first and listing later.

Insight 4: translating and republishing domestic promotional material is a common shortcut and a risk point.

Directly translating domestically approved claims and publishing them is the most common practice among foreign-linked companies, and the one most likely to trigger review problems. The claim scope and evidence standards approved domestically do not match the Korean review standards. Rewrite the Korean copy with the Korean-approved indications and intended use as the sole template.

Insight 5: with no statutory review period, there is no default turnaround to rely on.

Article 25 fixes only three periods — re-review application 30 days, objection 30 days, review validity 3 years — and does not set the processing period of the review institutions. No statutory period can serve as the review turnaround when planning promotions; confirm with the specific institution and keep records. Also easily overlooked: passing review is not permanent, and materials still circulating after 3 years must be reviewed again. The version ledger must therefore record the review approval date and the expiry date, not merely that the material was approved; the 30-day windows for re-review and objection run from the date the review result is received, and missing them forfeits the remedy.

4. Practical recommendations

• Confirm the applicable route before writing copy. Determine whether the product falls under the Digital Medical Products Act and whether it is professional-use, then choose between Article 25 review and the professional media exemption, as described in the guide on the Digital Medical Products Act.
• Maintain a materials list and version ledger. Number all outbound materials, noting review status, channels and validity, so old versions are recalled in step with new iterations.
• Use the approved scope as the sole template. Write copy directly from the Korean-approved intended use and performance specifications, whose sources are precisely the approval documents described in the guide on medical device labelling and IFU requirements.
• Write the professional media scope as a positive list. List the media allowed for placement, place nothing outside the list, and retain the basis for each judgement.
• Treat direct translation of domestic promotional material as a high-risk shortcut. Translating and publishing domestically approved claims is likely to trigger review problems; rewrite the Korean copy with the Korean-approved intended use as the sole template.
• Plan insurance listing in parallel. For software devices with reimbursement ambitions, schedule the notifications to the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service in the same project plan, as discussed in the guide on common misconceptions of Chinese manufacturers in the Korean market.
• Bring distributor materials under control too. State in distribution agreements that unreviewed or unauthorised materials must not be published, with accountability clauses retained.

5. Verification checklist

• □ Applicability determination: determine whether the product is a digital medical product and whether it is designated professional-use; the conclusion has a source and the review or exemption route is set.
• □ Self-regulatory review status: check the review conclusions and validity of every material against Article 25; all published materials have approval records or a lawful exemption basis, and none exceeds the 3-year validity.
• □ Copy template: compare copy with the Korean-approved intended use and performance specifications; no statement exceeds the approved scope.
• □ Placement channels: check the actual placement scope against the professional media positive list; nothing goes beyond the restricted channels and judgement bases are retained.
• □ Version ledger: sample material numbering, review status and recall records; old versions are deactivated and no parallel publication exists.
• □ Distributor control: check distribution agreement clauses and authorisation records; clear placement restrictions and accountability terms exist.
• □ Insurance linkage: check whether health insurance listing planning is in place; for products with reimbursement ambitions, the notification action is scheduled in the project plan.

Regulatory information verified as of October 29, 2026.

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 adverse event reporting and recall coordination with MFDS, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com