Handbook of medical device regulatory affairs in Asia /
"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 q...
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Group Author: | ; |
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Published: |
Pan Stanford Publishing,
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Publisher Address: | Singapore : |
Publication Dates: | [2018] |
Literature type: | Book |
Language: | English |
Edition: | Second edition. |
Subjects: | |
Summary: |
"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, clini |
Carrier Form: | xxxiv, 620 pages : illustrations ; 24 cm |
Bibliography: | Includes bibliographical references and index. |
ISBN: |
9789814774314 9814774316 |
Index Number: | R856 |
CLC: | R318.6 |
Call Number: | R318.6/H236/2nd ed. |