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Handbook of medical device regulatory affairs in Asia

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Handbook of medical device regulatory affairs in Asiaedited by Jack Wong, Raymond K.Y. Tong.
其他作者:	Wong, Jack.
出版者:	Singapore :Pan Stanford Publishing,c2018.
面頁冊數:	1 online resource (xxxiv, 620 p.) :ill.
標題:	Medical instruments and apparatusSafety regulationsAsia.
電子資源:	https://www.taylorfrancis.com/books/9780429504396
ISBN:	9780429504396$q(electronic bk.)

Handbook of medical device regulatory affairs in Asia
Handbook of medical device regulatory affairs in Asia[electronic resource] /edited by Jack Wong, Raymond K.Y. Tong. - 2nd ed. - Singapore :Pan Stanford Publishing,c2018. - 1 online resource (xxxiv, 620 p.) :ill.

Includes bibliographical references and index.

"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.

ISBN: 9780429504396$q(electronic bk.)

Standard No.: 10.1201/9780429504396 doiSubjects--Topical Terms:

948268
Medical instruments and apparatus
--Safety regulations--Asia.

LC Class. No.: R856.15 / .H36 2018

Dewey Class. No.: 610.28 / H236

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250 $a 2nd ed.
260 $a Singapore : $b Pan Stanford Publishing, $c c2018.
300 $a 1 online resource (xxxiv, 620 p.) : $b ill.
504 $a Includes bibliographical references and index.
520 $a "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.
588 $a Description based on print version record.
650 0 $a Medical instruments and apparatus $x Safety regulations $z Asia. $3 948268
650 0 $a Medical instruments and apparatus $x Standards $v Handbooks, manuals, etc. $3 948269
700 1 $a Wong, Jack. $3 948266
700 1 $a Tong, Raymond. $3 948267
856 4 0 $u https://www.taylorfrancis.com/books/9780429504396