1. Background
- With the amendment of the Medical Devices Act, legal grounds have been established for the revocation of Good Manufacturing Practice (GMP) compliance certification and the issuance of corrective orders. Consequently, it is necessary to specify the types of violations and the criteria for administrative dispositions in the subordinate statutes.
- Previously, the lack of clear disposition criteria for each type of violation raised concerns regarding reduced consistency and predictability of dispositions. Furthermore, there were limitations in systematically managing quality control violations. This amendment aims to strengthen the management system by specifying the types of violations and establishing clear disposition criteria.
2. Details of Regulation
- Violations occurring after obtaining GMP compliance certification—such as omitting records, falsifying documents, or failing to follow procedures—will be categorized into specific types. Additionally, disposition criteria, including corrective orders and the revocation of compliance certification, will be prescribed based on the severity of the violation.
