Handbook of medical device regulatory affairs in Asia[electronic resource]
- 其他作者: Wong, Jack. , Tong, Raymond.
- 出版: Singapore : Pan Stanford Publishing c2018.
- 版本: 2nd ed.
- 稽核項: 1 online resource (xxxiv, 620 p.) :ill.
- 標題: Medical instruments and apparatus Standards -- Handbooks, manuals, etc. , Medical instruments and apparatus , Safety regulations , Medical instruments and apparatus Safety regulations -- Asia. , Standards
- ISBN: 0429996756 , 9780429996757
- ISBN: 9789814774314
- 試查全文@TNUA:
- 附註: Includes bibliographical references and index.
- 摘要: "Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs."--Provided by publisher.
- 電子資源: https://dbs.tnua.edu.tw/login?url=https://www.taylorfrancis.com/books/9780429504396
- 系統號: 005330612
- 資料類型: 電子書
- 讀者標籤: 需登入
- 引用網址: 複製連結
"Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs."--Provided by publisher.
來源: Google Book
來源: Google Book
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