Handbook of medical device regulatory affairs in Asia / edited by Jack Wong, Raymond K.Y. Tong.
| Other author | Wong, Jack. |
| Other author | Tong, Raymond (Raymond Kai-yu) |
| Format | Electronic |
| Edition | Second edition. |
| Publication Info | Singapore : Pan Stanford Publishing, [2018] |
| Description | xxxiv, 620 pages : illustrations |
| Supplemental Content | Full text available from Taylor & Francis eBooks |
| Subjects |
| Variant title | Medical device regulatory affairs in Asia |
| Scope and content | "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. |
| Bibliography note | Includes bibliographical references and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Genre/form | Electronic books. |
| ISBN | 9789814774314 (hbk.) |
| ISBN | 9814774316 (hbk.) |
| ISBN | (electronic bk.) |
| ISBN | (electronic bk.) |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |