醫療器材管理法中全生命週期管理與風險分級的理念與功能【本期企劃】   試閱

The Concept and Function of Total Product Life Cycle Management and Risk Classification in Medical Devices Act

牛惠之

醫療器材是符合我國科研能力與產業現況，且具國際競爭力的產業類型之一。於2021年生效的「醫療器材管理法」中設置了全生命週期管理與風險分級兩項機制，確保醫療器材從研發、產製、運用都能符合安全、效能與品質的要求，並與國際主要規範接軌。本文將對這兩項機制的管理理念，與主要措施與可能成效進行探討。

Medical devices is one of the industrial sectors that benefited from the capabilities in scientific research and industrial conditions in Taiwan, demonstrating considerable international competitiveness. The “Medical Devices Act,” which came into effect in the year 2021, introduces two major mechanisms, namely, total product life cycle management and risk classification, ensuring that medical devices meet safety, effectiveness, and quality requirements throughout the stages of research and development, production, and utilization. These mechanisms are designed to align with major international standards. This paper aims to explore the management principles of these two mechanisms, along with the key measures and potential outcomes.

007-021

全生命週期管理、風險分級、食品藥物管理署、醫療器材、醫療器材管理法、total product life cycle management、risk classification、Taiwan food and drug administration、medical devices、Medical Devices Act

月旦醫事法報告

202402 (88期)

元照出版公司

10.53106/241553062024020088001  複製DOI  DOI查詢

企劃導讀

醫療器材之產品責任【本期企劃】