臺灣智慧醫療器材之立法與監管新趨勢

New trends in legislation and regulations for eHealth devices in Taiwan

「智慧醫療」正如火如荼地重新形塑今日吾人之醫療照護模式，同時亦是我國近年積極佈局之重點產業。智慧醫療器材具備以軟體技術為核心、產品生命週期短及潛在黑箱性等特徵，與傳統醫療器材在本質上具有明顯差異。我國於2021年施行「醫療器材管理法」，在該法及相關法規之規範架構下，我國關於智慧醫療器材之上市前審查與上市後監督，已形成一定運作機制。為因應智慧醫療器材講求發展速度之特性，實務及學說多有肯認應適度放寬其上市前審查。而在「醫療器材管理法」施行後，我國對於醫療器材之上市前審查亦趨於鬆綁，但在智慧醫療器材之上市前審查程序，則流於單調，對於種類龐雜之智慧醫療器材，恐欠缺彈性。
另一方面，相應於放寬之上市前審查程序，智慧醫療器材之上市後監督機制益顯重要，方能保障民眾權益。我國「醫療器材管理法」對於醫療產品之上市後監督雖設有追蹤追溯及安全監督等機制，但在運作上仍係委由主管機關食藥署之主動稽查與取締，恐亦不足以處理種類龐多、機制複雜之智慧醫療器材，對於民眾之資訊安全，亦尚未建立嚴密之保護機制。捨棄傳統行政機關一元管制模式，而藉由產品資訊公開訴諸行政機關與醫療專家「共同治理」，應係較合理且周全之智慧醫療器材管制模式，以在產品安全及產業創新之間達至均衡點。

eHealth is vehemently reshaping our current medical care model. Moreover, it is a key industry that Taiwan has actively deployed in recent years. The eHealth deviceshave the characteristics of software technology as the core, short product life cycle, and potential black box, which are significantly different from traditional medical devices in essence. To address the rapid development of eHealth devices,the“Medical DevicesAct”has been implemented in Taiwan since 2021.Under the framework of the Medical DevicesAct and related regulations, Taiwan has formed an operating mechanism for pre-market review and post-market surveillance of eHealth devices. In response to the characteristics of eHealth devices that emphasize the speed of development, it has been proposed that the pre-market review process should be relaxed. After the implementation of the Medical DevicesAct, Taiwan's pre-market review of medical devices has also tended to loosen, however, it appears that the review process lacks the flexibility to address the myriad eHealth devices.
On the other hand, corresponding to the relaxation of the pre-market review process, the post-market surveillance of eHealth devices becomes crucial to protect the health of the public. Although the Medical DevicesAct stipulates tracking system and safety supervision for the post-market surveillance of medical devices, the operation still depends on the active inspection by the Taiwan FDA. Unfortunately, the wide variety and complexity of eHealth devices are beyond the scope that the Taiwan FDA can cope with. Adopting a more flexible approach, that is, ''collaborative governance'' by both the Taiwan FDA and medical experts, will be a more reasonable regulatory model to achieve the desired balance between product safety and industrial innovation.