Handbook of medical device regulatory affairs in Asia /

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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:
Medical instruments and apparatus > Asia > Handbooks, manuals, etc.
Medical instruments and apparatus > Standards > Asia > Handbooks, manuals, etc.
Equipment and Supplies > standards
Equipment and Supplies > standards > Asia.
Médecine > Appareils et instruments > Asie > Guides, manuels, etc.
MEDICAL > Instruments & Supplies.
Medical instruments and apparatus
Medical instruments and apparatus > Standards
Asia
Electronic books.
Handbooks and manuals
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

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