Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

ISBN 10: 9814774316 / ISBN 13: 9789814774314

Edité par Jenny Stanford Publishing, 2018

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Détails bibliographiques

• Titre: Handbook of Medical Device Regulatory Affairs in Asia: Second Edition
• Éditeur: Jenny Stanford Publishing
• Date de parution: 2018
• Langue: anglais
• ISBN à 10 chiffres: 9814774316
• ISBN à 13 chiffres: 9789814774314
• Reliure: Couverture rigide
• Édition: 2ème Édition
• État de l'article: New

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Synopsis

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.

À propos de l?auteur

Jack Wong is regulatory affairs head, Asia Pacific, at Baxter Healthcare. He has more than 20 years of experience in regulatory affairs, clinical trials, and pharmacovigilance in Asia with good knowledge in the field of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products.

Raymond Tong is professor and founding chair in the Department of Biomedical Engineering, the Chinese University of Hong Kong; chair, the Hong Kong Local Responsible Person Panel; chair of the Asia Regulatory Professional Association (ARPA)-Hong Kong Academy; and honorary advisor of the Hong Kong Medical and Healthcare Device Industries Association.