我國的醫療器材多半仰賴代理模式,在選擇醫療器材供應商及代理產品時,除了要瞭解產品的市場需求、產品財務指標之外,現在狀況下醫療器材上市必須符合許多法規的的要求,無論是查廠登記、許可證申請或健保給付的要求等,所以多方面的考量才能選定的醫療器材順利的上市並且有好的銷售結果。 本次研究是將博而美國際股份有限公司多年的代理經驗加上相關文獻資料及法規規範等,設計成符合FAHP 的問卷格式,在邀請醫療產業負責執行代理的專家訪談後,利用 FAHP 計算出權重,在構面部分以供應商條件指標(44.56%)最為重要,其次為健保申請因素指標(17.85%)、供應商產品銷售服務指標(15.10%)、提供許可證申請指標(14.95%)及提供查廠登記(QSD)申請指標(7.81%),在準則部分以醫療產品製程品質能力(24.79%)及醫療產品研發技術能力(11.55%)最為重要。 上述構面及準則藉由決策模式的FAHP 的權重分析後,讓未來在評估新的醫療器材代理及供應商選擇時對於考慮的條件有優先順序的排序,希望這樣的研究可以減少選擇上的盲點。
In Taiwan, medical equipments mostly rely on the distribution model. When choosing medical equipments suppliers and distributing products, it is necessary to understand product market demand, product financial indicators, and if the medical equipment’s comply with current regulations, including Quality System Documents, license application and health insurance payment requirements. Consideration in all aspects can successfully bring selected medical equipments to the market and lead to great sales. In this research, a questionnaire that meets FAHP guidelines was designed based on TBMS International Corporation Limited’s years of distribution experience, relevant documents and regulations. After interviewing with medical industry experts, the weights were calculated according to FAHP. The most important index is Supplier Condition Index (44.56%), following by Indicators of Health Insurance Application Factors (17.85%), Vendor Product Sales Service Index (15.10%), License Application Indicator (14.95%) and Application for Quality System Documents (7.81%). As of criteria, Quality of medical products manufacturing process (24.79%) and Medical product R&D capability (11.55%) are the most critical factors. Above mentioned aspects and criteria were analyzed by FAHP weights in order to develop a prioritization for future evaluation of new medical device agents and supplier selection. It is expected that this study will help reduce any blindness in medical products selection.
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