Medical Device Advertising Pre-Review: Scope and Procedure — 3-Year Validity, Re-Review Within 30 Days

Procedure

1. 1. Check whether the medium is subject to review

   Advertisements on television and radio, general daily and weekly newspapers, internet newspapers and magazines, banners, posters, leaflets, transit facilities and vehicles, and electronic display boards are subject to review. Internet news services, broadcasters' websites, internet media (including apps) operated by mail-order sellers or mail-order brokers, and social media with an average of 100,000 or more daily users over the 3 months before the end of the previous year are also included. First check whether product detail pages on online marketplaces and your own online store fall under these media.

2. 2. Check whether an exemption applies

   Advertisements consisting only of approved, certified or reported content, foreign-language advertisements for devices produced only for export, and foreign-language advertisements identical to already reviewed content may be exempt from review. Advertisements delivering professional content to medical personnel, medical institution founders, medical technicians, health information managers and opticians are also exempt. If even one line goes beyond the approved content, the exemption does not apply, so compare each phrase.

3. 3. Check prohibited expressions and prepare the draft

   Annex 7 of the Enforcement Rule of the Medical Devices Act prohibits advertising unapproved efficacy or performance, absolute expressions such as "best" or "top", before-and-after comparisons implying results, advertisements that may be mistaken as endorsed or recommended by doctors, and advertisements disparaging other products. For video, check the script, captions, visuals and narration, and for print and detail pages, check the text, photos and designs against the intended use on the approval. Organize the approved items or test data supporting each expression.

4. 4. Apply to the self-regulatory review body

   The review follows the standards, methods and procedures set by the self-regulatory review body that has reported to the Ministry of Food and Drug Safety, and that body also sets the fee. Submit the application with the advertising draft, a copy of the approval and other materials the body requires, and receive notice of the result. If you disagree, request a re-review stating the purpose and reasons within 30 days of notice, and the body must notify the result within 10 days.

5. 5. Manage publication, changes and renewal after approval

   You may advertise as reviewed for 3 years from approval, and to continue you must apply again 6 months before the validity expires. If you change the advertisement content you must be reviewed again, except for wording or layout changes that do not alter the content, or changes reflecting a change approval, change certification or change report. If you still disagree with the re-review result, file an objection with the Ministry of Food and Drug Safety within 30 days.

Required documents

• Medical device advertising review application (form set by the self-regulatory review body; no statutory form)
• Advertising draft (script and storyboard for video, final draft for print and detail pages)
• Copy of the medical device product approval, certification or report certificate
• Instructions for use or package insert
• Supporting materials for advertising claims (test reports, papers, etc., if required by the body)
• Re-review request (if you disagree, stating the purpose and reasons)
• Objection to the re-review result of a medical device advertisement (Enforcement Rule of the Medical Devices Act, Form No. 38-2, for objections to the Ministry of Food and Drug Safety)
• Letter of authorization (when submitted by an agent)

Fees

Industry range of several hundred thousand won to several million won · We will quote after consultation based on the number of media, whether it is video or print and detail pages, the number of revisions, and whether re-review or objection is included. The review fee of the self-regulatory review body is separate.

See fees and official charges for this service →

Legal basis and review date

• Medical Devices Act, Article 24
• Medical Devices Act, Article 25
• Medical Devices Act, Article 25-2
• Medical Devices Act, Article 36
• Medical Devices Act, Article 52
• Enforcement Decree of the Medical Devices Act, Article 10-3
• Enforcement Decree of the Medical Devices Act, Article 10-4
• Enforcement Rule of the Medical Devices Act, Article 45
• Enforcement Rule of the Medical Devices Act, Article 45-2
• Enforcement Rule of the Medical Devices Act, Annex 7

Checked against the statutes on 2026-10-07

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• A re-review must be requested within 30 days of notice of the result, and an objection to the Ministry of Food and Drug Safety within 30 days of notice of the re-review result, so record the date you received each notice.
• Renewal must be filed 6 months before the 3-year validity ends, so put the date 2 years and 6 months after approval in your schedule.

Frequently asked questions