(1) Reasons for Proposal

With amendments to the Medical Devices Act and the Enforcement Decree thereof to introduce an advertisement independent review system by a private-sector independent review organization, this Partial Amendment aims to define monitoring procedures as delegated to the Ordinance of the Prime Minister.

(2) Major Provisions

A. Monitoring method for a medical device advertisement independent review organization (Article 45-2)

1) Define specifics including procedures and methods with an amendment to the Medical Devices Act to require a medical device advertisement independent review organization to monitor the advertisement it has reviewed and submit monitoring results to the Minister of Food and Drug Safety.

2) Require an independent review organization to monitor whether the reviewed advertisement violates prohibitions under Article 24 paragraphs 3 of the Act and paragraph 3 and submit monitoring results to the Minister of Food and Drug Safety every quarter.

3) Ensure independence in medical device advertisement review and prevent consumer harm by monitoring any violation in advertisements.