[Background]

To manage and supervise handlers involved in the manufacturing, importation, and sale of medical devices, there is a need to establish a legal basis allowing the Minister of Food and Drug Safety to order handlers to submit necessary reports, enter the relevant premises to conduct inspections or ask questions, and require the submission of necessary documents, while also clearly prescribing sanctions for non-compliance.

Previously, when handlers refused to submit materials by citing a lack of explicit legal grounds, it caused potential disputes and delays in administrative actions.

Therefore, government intervention is necessary to clarify the statutory scope of administrative investigations, thereby securing the speed and accuracy of such investigations.

[Main Points]

Addition of the authority to require handlers and related parties to submit documents, and the application of administrative sanctions and penalties in the event of refusal or obstruction.