(1) Reasons for Proposal

With the introduction of a self-review system for advertisements through a private self-review body due to the amendment to the Medical Devices Act, the Amendment aims to stipulate matters entrusted to subordinate statutes.

(2) Major Provisions

A. Clearly stipulate Internet media, etc., which are subject to self-review of advertisements (Article 10-3 newly inserted)

1) Since the amendment has entrusted the Internet media among the media that require self-review for advertisements through a self-review body under Presidential Decree, it is necessary to prescribe thereof. 

2) Designate Internet news services, Internet websites operated by broadcasting operators, Internet media operated by information and communications service providers, and social network services with average daily users of 100,000 or more as Internet media.

2) The clear stipulation of Internet media that require advertising review is expected to secure legal clarity and predictability of civil petitioners.

B. Clarification of those eligible to be exempt from the modification of advertisement review (Article 10-4 newly inserted)

1) Due to the amendment to the Medical Devices Act, since the targets permitted to advertise without any additional review of the content that has undergone self-review for advertisements are so entrusted under Presidential Decree, it is necessary to clearly stipulate the targets. 

2) Where the reviewed expressions in the advertisements are not modified or deleted but the placement of phrases or drawings are modified but only to the extent that the content of the reviewed advertisement is not modified, it is stipulated that the advertisement shall be exempt from undergoing modification review.

3) Since minor modifications have been excluded from the targets of modification review, the efficiency of administration and convenience of civil petitions are expected to increase. 

C. Clarification of those eligible for exemption from advertisement review (Article 10-5 newly inserted)

1) Since the advertisements set out by Presidential Decree such as those targeting a group of experts, including medical personnel, under the law do not require the review of the self-review body, it is necessary to prescribe the targets. 

2) Exclude those advertisements aimed at delivering professional information to medical personnel, medical service technologists, opticians, etc., from those subject to review. 

3) Since any information provided to experts such as medical personnel is exempt from receiving advertising review, reasonable regulation and operation are expected. 

D. Establishment of the procedures for re-review of advertisements, etc. (Article 10-6 newly inserted)

1) If there is an objection to the advertising review result of the self-review body under the Act, the party may apply for re-review as prescribed by Presidential Decree, and if there is still an objection to the re-review result, the party shall be allowed to raise an objection again. Therefore, it is necessary to set out detailed procedures thereof. 

2) Where there is an objection to the review result of the self-review body, allow the party to specify the reasons for such objection within 30 days from the review and file an application for re-review. If there is still an objection to the re-review result, allow the party to fill out an objection application and file it with the Minister of Food and Drug Safety. 

3) The Amendment is expected to clearly stipulate the re-review and objection application procedures as entrusted under the Act to secure legal clarity and predictability of civil petitioners. 

E. Procedures and requirements for reporting by the self-review body (Article 10-8 newly inserted)

1) According to the Act, the self-review body is required to have an organization for self-review as prescribed under Presidential Decree, and thus, it is necessary to stipulate requirements and reporting procedures therefor. 

2) Prescribe matters on the organization and facilities that a self-review body are required to have and set the standards of an agency or organization eligible to apply as a self-review body.

3) The Amendment is expected to clearly stipulate the application, requirements, etc., of the self-review body to satisfy the requirements for advertising review and secure legal clarity.