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In Taiwan, the "Regulations of Medical Device Good Distribution Practice" is the rule for safe handling and distribution of medical devices from the manufacturer to the end-user. TFDA under the Ministry of Health and Welfare established this regulation to ensure the safe and effective distribution of medical devices.

 

The regulation includes requirements for storage, transportation, and handling of medical devices, as well as the responsibilities of different parties involved in the distribution process.

 

After getting a medical device license, foreign manufacturers must designate an in-country representative in Taiwan as the license holder, who can authorize desired distributors to use the product license for importation. Both the license holder and distributors must comply with GDP regulations as per the Medical Device Act.

 

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K&C helps medical device firms get GDP certificates and establish effective communication to create a complete quality system for product distribution based on its extensive experience.

Good Distribution Practice
Our Services Include:
 

  • Gap assessment between the current distribution process and the regulatory requirements.

  • Consultation on the regulations and the quality system for product distribution.

  • Assistance in establishing quality system documents and providing solutions for product storage and transportation.

  • Inspection of the existing quality system and providing CAPA plans.

  • Maintenance of the quality system, including but not limited to providing guidance on the conduction of internal audits, corrective and preventive actions, and management review.

  • Providing suggestions on the CAPA plans in response to the TFDA onsite audit.

在台灣，醫療器材的運輸儲存是由“醫療器材優良運銷準則”所規範，該準則是由台灣衛福部食品藥物管理署(TFDA)制定。

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“醫療器材優良運銷準則”旨在確保自製造廠至使用者，於台灣境內供應鏈中各方皆以妥善方式儲存與運輸醫療器材，而不致影響醫療器材之安全性與有效性。準則中詳細規範了儲存、運輸與交付醫療器材時應遵守之原則，並定義了供應鏈各方之責任義務。

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取得醫療器材許可證後，國外製造廠(Foreign Manufacturer)應指定台灣境內實體為代理人(In-Country Representative)，作為許可證持有者(License Holder)，許可證持有者可以授權國外製造廠指定之經銷商使用產品許可證以做產品進口使用。而依據醫療器材管理法規範，許可證持有者以及被授權使用產品許可證之經銷商，都應該取得GDP核可。

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從醫療器材管理法正式公告至今，K&C已成功輔導眾多醫療器材商取得醫療器材優良運銷許可，透過廣泛客群中累積的經驗，以專業的態度，與您建立有效溝通，提供解決方案，輔助建立完善的運銷品質系統。

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輔導實績：

埃默高有限公司、博而美國際股份有限公司、宏陽生物科技有限公司、宏國醫療儀器有限公司、科利耳有限公司、海鷹科技有限公司、讚賀生醫股份有限公司等

輔導內容

  • 醫療器材商現行運銷系統法規符合性評估

  • 醫療器材優良運銷準則法規諮詢及常見問題解析

  • 依據「醫療器材優良運銷準則」協助醫療器材商品質系統文件、產品儲存運輸方式建置

  • 品質系統運行問題確認並提供解決方案

  • 協助公司內部稽核、矯正預防措施、管理階層審查等活動的進行

  • 依據TFDA評鑑機構GDP查核結果，提供改善建議。

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