醫療器材優良運銷模式之建構與品質系統導入之應用 —以Q生物科技公司為例

Abstract

醫療器材GDP（Good Distribution Practice，優良運銷準則）是確保醫療器材在儲存、運輸、配送與販售過程中品質得以維持的重要規範。實施GDP能確保醫療器材在運銷過程中，品質符合原製造業者的要求，不影響其安全及效能，保障民眾用藥安全。 本研究藉著個案研究導入“優良運銷規範GDP＂導入時期，便積極參與各種教育訓練及品質系統制定，最後取得 “衛生福利部＂認證，並使公司能繼續擁有有效的“醫療器材GDP許可證＂，使企業在醫療器材銷售上得以永續經營。

Medical Device GDP (Good Distribution Practice) is an essential regulation that ensures the quality of medical devices is maintained during storage, transportation, distribution, and sales. Implementing GDP ensures that the quality of medical devices meets the original manufacturer's requirements throughout the distribution process, does not affect their safety and effectiveness, and safeguards public medication safety. This case study focuses on an active participation in various training sessions and quality system establishment during the implementation of "Good Distribution Practice (GDP)." The company successfully obtained certification from the "Ministry of Health and Welfare" and maintained a valid "Medical Device GDP License," enabling the company to achieve sustainable development in medical device sales.