(1) Reasons for Proposal

The Amendment provides grounds for revocation of the designation of medical device quality manager education institutions and improves a system for preliminary review of medical device advertisements that potentially violate the constitution, thereby aiming to remedy deficiencies detected in the enforcement of the Act.

(2) Major Provisions

A. Grounds for revocation, etc. of licenses for quality manager education institutions (Article 6-2)

1) Institutions that conduct education for medical device quality managers are being designated and operated under the Act. However, there are no provisions that can revoke the designation of said institutions in the event that they are found to have been granted said designation in a false and unjust method and conduct education affairs unjustly by issuing certificates (of completion) to persons who were not trained by them. This represents an imperfection in the current legislation.
2) The Amendment clearly provides grounds for the designation of quality manager education institutions and revocation of said designation and provides for a delegation of authority in matters such as the issuance, etc., of certificates, thereby aiming to secure the integrity of a legal system and remedy deficiencies in legislation.

B. Permission, etc. of changes in conditional permission (Article 12)

1) Article 12 of the Act stipulates that where any change occurs in any information regarding permission or certification already granted or a notification previously filed, a manufacturer shall obtain permission or certification for the change or file a notification of such change. However, a conditional permission, etc., issued with the condition being that a manufacturer will establish facilities and manufacturing and a quality control system are not subject to obtaining permission for said changes under Article 12. Hence, when a change of a representative of a manufacturer as a result of business transfer or takeover occurs, there is no clear provision that can enforce permission for such change, which represents a deficiency in the judicial system

2) Hence the Amendment clearly states that conditional permission is included in matters subject to permission of changes under Article 12 and remedies the deficiency in the legislation and clarifies the law.

C. Prohibition of quality managers who did not complete training from being engaged in business (Article 13)

1) The Act provides that a quality manager shall receive regular training every year, and that a manufacturer shall not interfere with the affairs of a quality manager, and where the quality manager requests matters necessary to conduct his/her affairs, a manufacturer shall not refuse such request without reasonable grounds, to ensure quality control. However, there is no clear provision that prevents a quality manager who did not receive training from being engaged in quality control affairs.
2) Hence the Amendment clearly provides the requirement that a manufacturer/importer shall not allow a quality manager who did not receive training to perform quality control affairs and violation of this requirement shall result in the imposition of an administrative fine of up to one million Korean won, thereby securing propriety in the duty performance of quality managers.

D. Ex officio cancellation of reporting requirement for closure of medical devices distribution and lease businesses (Article 17)

1) When a person intends to close business, he/she who is engaged in the business of distributing or leasing medical devices is required to report such closure of business to a competent tax office with respect to business registration under the Value-added Act and also report to a competent local government the close of such business for distribution under the Medical Devices Act, meaning the reporting requirement is duplicated. Therefore, there have occurred cases where a person reports a closure of business for business registration only to a competent tax office while not reporting the same to a local government, thereby incurring an administrative fine. Therefore, the duplicated reporting process needs to be unified.
2) Hence, in the event where the head of a competent tax office cancels a business registration as per the Value-added Tax Act, this Amendment ensures that the reporting requirement of the closure of a distribution business under the Medical Devices Act is cancelled ex officio and where necessary, upon request, the head of a competent tax office shall provide information as to whether or not a business is closed, thereby aiming to promote convenience in civil affairs and increase the efficiency of public administration.

E. Introduction of preliminary review of advertisements by a voluntary review organization for medical device advertisements (Article 25, Article 25-2, Article 25-3)
1) A request for a judgment on the unconstitutionality of the medical devices preliminary review system as per the Medical Devices Act has been filed. Due to the possibility of unconstitutionality, the system for preliminary review of medical device advertisements needs to be improved.
2) This amendment improves the system in such a way that an independent voluntary review organization, not a governmental agency, conducts the preliminary review of medical device advertisements and prevents the disorderly production of illegal medical device advertisements through continuous monitoring, thereby aiming to preclude elements of unconstitutionality regarding the preliminary review of medical device advertisements and minimize damage to people due to illegal advertisements.