Medical Devices Act Article 24
For medical devices announced by the central competent authority and their dealers, a medical device good distribution system shall be established to govern the product storage, distribution, services, personnel deployment, and other related operational matters, and shall comply with the regulations for good distribution practice of medical devices.Medical device dealers shall set up a good distribution system of medical devices in accordance with the regulations set forth in the preceding paragraph, and the wholesale, import, or export may only begin after receiving a compliance inspection by the central competent authority and obtaining a distribution license.Regulations for the good distribution practice set forth in Paragraph 1, and regulations governing the content and methods of inspection, the requirements, procedures, review, issuance, validity period, revocation, or cancellation of approval referred to in the preceding paragraph, and other matters to be complied with shall be established by the central competent authority.
中文原文 醫療器材管理法第24條
經中央主管機關公告之醫療器材及其販賣業者，應建立醫療器材優良運銷系統，就產品之儲存、運銷、服務、人員配置及其他相關作業事項予以規範，並應符合醫療器材優良運銷準則。
醫療器材販賣業者依前項準則規定建立醫療器材優良運銷系統，並報中央主管機關檢查合格，取得運銷許可後，始得批發、輸入或輸出。
第一項之優良運銷準則及前項檢查內容與方式、許可之條件、程序、審查、核發、效期、變更、撤銷或廢止及其他應遵行事項之辦法，由中央主管機關定之。
醫療器材販賣業者依前項準則規定建立醫療器材優良運銷系統，並報中央主管機關檢查合格，取得運銷許可後，始得批發、輸入或輸出。
第一項之優良運銷準則及前項檢查內容與方式、許可之條件、程序、審查、核發、效期、變更、撤銷或廢止及其他應遵行事項之辦法，由中央主管機關定之。