Handbook of medical device regulatory affairs in Asia / / Jack Wong, Raymond K.Y. Tong

• Autore: Wong Jack
• Pubblicazione: Boca Raton, Fla., : Pan Stanford Pub., 2013; Boca Raton, Fla. : , : CRC Press, , 2013
• Edizione: 1st ed.
• Descrizione fisica: 1 online resource (610 p.)
• Disciplina: 610.284
• Soggetto topico: Medical instruments and apparatus - Safety regulations - Asia; Medical instruments and apparatus - Standards
• Altri autori: TongRaymond (Raymond Kai-yu)
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: pt. 1. Introduction -- pt. 2. Medical device safety and related ISO standards -- pt. 3. Harmonization of medical devices in Asia -- pt. 4. Medical device regulatory system in the United States and the European Union -- pt. 5. Medical device regulatory system in Asia-Pacific region.
• Sommario/riassunto: 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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in
• Titolo autorizzato: Handbook of medical device regulatory affairs in Asia
• ISBN: 0-429-07135-3; 981-4411-22-1
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910822784403321
• Lo trovi qui: Univ. Federico II