醫療器材取得國際認證之道： 台灣牙科植體發展之案例分析

Abstract

本研究之目的是探討醫療器材如何取得國際認證及上市，並以台灣牙科植體之發展現況進行分析，且就國際市場現況進行評估，希望提供醫療界與產業界相關資訊，並希望實際提供施政單位參考以積極協助我國醫療器材產業之國際化。本研究之方法是蒐集整理各主要國家之國際認證及相關法規，再以台灣植體之案例分析探討業者如何取得認證與上市。並分析台灣牙科植體產業的國際競爭力與進入國際市場之選擇性。研究結果發現:一般而言，在申請國際認證之前，由於申請GMP認證才能進行工廠運作，申請台灣認證TFDA 認證，才能搶先進入台灣市場，因此牙科醫療器材業者會先探討醫療法規 、申請GMP認證、進行工廠運作、將設計進行專利申請、申請台灣認證TFDA 認證、進入台灣市場，之後，才會申請國際認證。而由於東南亞國協(ASEAN)之中，各個國家有不同的要求，ASEAN已積極進行醫療器材法規調和，業者頃向先申請歐盟CE認證，取得國際認證之憑據，再進行美國FDA認證，以作為未來進行中國大陸認證(SFDA)及東南亞認證之基礎。本論文進一步分析台灣牙科植體產業的國際競爭優勢、以及國際市場之選擇，以國家鑽石模型分析及CAGE分析結果顯示台灣的牙科植體器材在中國大陸及東南亞國家較具發展性。

The purposes of this study were to explore the international regulations and laws of medical devices certification and the methods to apply for marketing. The cases of the development of dental implants in Taiwan and their experiences for application of international medical devices certification and marketing were investigated. Through this study, hope, the references for medical professions and the industry sector be provided and the references for the government to promote the internationalization of our medical devices industry could be set up. The methods of the present studies were to collect international medical devices regulation and related laws of certification in major countries. The cases of developing dental implant industry in Taiwan were analyzed to explore the real experiences of the dental implant industry in obtaining the certification and marketing. The choice for international entrance of dental implant industry in Taiwan. The results demonstrated that each country has specific medical device certification and related laws. From these 5 cases studies, it was found that they all applied GMP certification firstly in order to carry out the operation and then did patent application. After that, TFDA certification was applied for marketing entrance in Taiwan. And then applied for medical device certification in the European Union (CE) and medical device certification in the USA (FDA). It was confirmed that the international markets in Mainland China and ASEAN are the first choices for international entrance.