QT ANALYSIS: 台灣醫療器械法規和費用的重要變更
- 2021-04-20 03:47:45
由理工科技為您整理台灣衛生福利部食品藥物管理署最新公布之醫療器械法規和費用的重要變更。
了解更多由理工科技為您帶來台灣衛生福利部食品藥物管理署最新公布之藥品優良運銷規範GDP檢查實施時程流程圖!
了解更多Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.
了解更多Hong Kong boasts a wealthy and sophisticated medical device market. With the medical technology industry being one of the major driving forces for the country’s booming economy, in this edition of QT Analysis, we delve deep into the reasons why it is a booming medical device market in Asia and how you shouldn’t miss out on the great business opportunities it offers.
了解更多TFDA has announced a new draft about Good Distribution Practice (GDP). This practice requires distributors who import and/or sell medical devices or who hold medical device registration licenses (license holders) to set up a good distribution system. This is to ensure their quality and integrity are constantly maintained. In this article we have listed important points for distributors to comply with the GDP guideline, throughout the process of importation, transportation, storage, sale and post-market services competent authority and obtaining a distribution license.
了解更多AI based SaMD is getting more traction in ASEAN counties, owing to their huge potential to transform healthcare industry. At the same time, local regulatory bodies are getting stricter in the evaluation of these AI based SaMD, for added safety and ensuring smooth performance. In this issue of QT Analysis, we are looking into the requirements for registering and marketing these AI based SaMD in selected ASEAN countries.
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