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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 quality...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Wong, Jack, Tong, Raymond (Raymond Kai-yu)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Boca Raton : CRC Press, ©2013.
Temas:
Acceso en línea:Texto completo

MARC

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245 0 0 |a Handbook of medical device regulatory affairs in Asia /  |c Jack Wong, Raymond K.Y. Tong, [editors]. 
260 |a Boca Raton :  |b CRC Press,  |c ©2013. 
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505 0 |a 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. 
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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in. 
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