Medical Device Advertisement Pre-Review (Application to a Self-Regulatory Review Body)

Procedure

Procedure

1. 01

   Confirm the review-target medium: Check whether the advertisement appears on television or radio, in general daily or weekly newspapers, internet newspapers or magazines, on banners, posters, leaflets, transport facilities or vehicles, or on electronic signboards. Internet media (including apps) run by mail-order sellers or intermediaries and SNS with 100,000 or more daily average users over the last three months of the previous year are also covered, so first decide whether open-market and own-mall product pages fall within this.

2. 02

   Check exemptions: Advertisements made up only of permitted, certified or reported content, foreign-language advertisements for export-only devices, and foreign-language advertisements identical to already reviewed content may be exempt, as may professional advertisements aimed at medical personnel, medical institution founders, medical technicians, health information managers and opticians. A single expression outside the permitted scope removes the exemption, so compare the copy line by line.

3. 03

   Screen prohibited expressions and organize evidence: Under Annex 7 of the Enforcement Rule, advertisements claiming unpermitted efficacy, denying all side effects, using testimonials, using absolute terms such as "best" or "top", showing before-and-after comparisons, citing recommendations by doctors or professors, or disparaging other products are prohibited. Compare the script, subtitles, visuals and narration of videos, or the copy and photos of product pages, with the intended use on the permit, and attach the permit item or test data supporting each expression.

4. 04

   Apply to the self-regulatory review body: Review follows the standards, methods and procedures set by the body reported to the Ministry of Food and Drug Safety, and the fee is also set by that body. Submit the body's application form with the advertisement draft, a copy of the product permit, the instructions for use and supporting data. Once approved, you may advertise as reviewed for 3 years from the approval date.

5. 05

   Check the result and request re-review or objection: If you disagree with the result, request a re-review from the reviewing body within 30 days of notice, stating the purpose and reasons; the body must report the result within 10 days of the request. If you still disagree, submit the objection form (Form No. 38-2) to the Minister of Food and Drug Safety within 30 days of notice; the processing period is 30 days from receipt.

6. 06

   Manage changes and renewal after approval: Changing approved content requires a new review unless the change is minor, such as editing wording or layout without changing the content, or revising to match a changed permit, certification or report. To keep advertising after the 3-year validity ends, apply again 6 months before expiry, so mark the date 2 years and 6 months after approval in your calendar.

Filing route

Filing route

Deadlines & processing notes

Deadlines & processing notes

Basic documents

Basic documents

Even a small change to wording or visuals after review makes the advertisement differ from the reviewed content and violates Article 24(2) of the Medical Devices Act unless it is a minor change, so confirm each time that an edit stays at the level of wording.