新南向國家及臺灣醫療器材上市前管理法規研析【本期企劃】 試閱
Analysis of Medical Device Pre-Marketing Regulations in New Southbound Policy Countries and Taiwan
醫療器材與一般商品不同，於上市前須經審查，由主管機關把關其安全、品質及效能，故業者須遵循各國主管機關所訂定之上市前審查制度，符合相關管理規範後始得於該國上市。本文透過介紹分析新南向國家與臺灣醫療器材上市前管理規定，使各界初步了解醫療器材上市前管理，此外，亦能協助臺灣業者降低醫療器材外銷至新南向國家之阻礙，促進臺灣產業發展並進而滿足當地快速增加之醫療及高齡健康照護需求，提升醫療及照護品質。
The management of medical devices is different from general products. Medical device firms must submit the documents to the competent authority for pre-marketing review before the products are released. The responsibility of competent authority is to confirm the safety, efficacy, and quality of the medical devices. In other words, the firms must follow the pre-marketing review regulations prescribed by the competent authority, moreover, medical device products couldn’t be launched on the market until they have met the management regulations of the country. Introducing the concept of medical device premarket management in this article might not only help industries to avoid breaking the rules, but also assist the vendors to expand marketing layout and reduce the export resistance, thus might promote the quality of medical service both in Taiwan and New Southbound Policy countries.
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