1. Reasons for Amendment

  The proposed changes aim to address certain deficiencies in the current regulations by allowing the issuance of correction orders to facilities of in vitro diagnostic medical device manufacturers when they do not meet the standards, as per the amendment to the In Vitro Diagnostic Medical Devices Act (effective from February 17, 2024).  Additionally, the proposal seeks to establish disposal criteria for cases of noncompliance with correction orders and to revise certain provisions to exempt manufacturing and importing businesses from permits, taking into consideration the characteristics of in vitro diagnostic medical devices.

2. Major Provisions

A. Clarification of Exemptions for In Vitro Diagnostic Medical Device Manufacturing and Importing Permits (Article 5-2, Article 26-2)

  Currently, exemptions for manufacturing and importing permits for in vitro diagnostic medical devices are based on the Medical Device Act. This provision aims to specify the legal basis for exemptions that are appropriate for the characteristics of in vitro diagnostic medical devices.

B. Establishment of Administrative Measures for Noncompliance with Improvement Orders (Annex Table 1)

  In cases where the facilities of in vitro diagnostic medical device manufacturers or importers do not meet the standards, the Medical Device Act has been amended to allow for improvement orders to be issued for such facilities. To enhance the effectiveness of regulations, new criteria for administrative measures in the event of noncompliance with improvement orders are to be introduced.