Handbook of Medical Device Regulatory Affairs in Asia: Second Edition

ISBN-13: 9789814774314 / Angielski / Twarda / 2018 / 620 str.

Jack Wong; Raymond Tong

Opis

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.

Spis treści

How to Train University Students in RA Raymond K. Y. Tong  The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals David Martin and Neil Lesser  The Role of the Asia Regulatory Affairs Team in Relation to the Commercial Team and Other Departments Fredrik Dalborg  Commercial Sense and What It Means for a Regulatory Manager or Executive Annie Joseph  Medical Device Regulatory Strategy: Product Development and Product Registration in Asia and Global May Ng et al.  Regulatory Affairs as a Business Partner Claudette Joyce C. Perilla  Introduction to Regulatory Affairs Professionals’ Roles Dacia Su  What It Means to Be a Medtech Regulatory Journalist Amanda Maxwell  Affordable Access to Medical Devices in Developing Countries Rosanna W. Peeling and Tikki Pang Regulatory Specialists in Medical Devices in Europe—Meeting the Challenge of Keeping Current in a Changing Environment: How TOPRA Supports Professionals in a Dynamic Industry Lynda J. Wight  Biomedical Device: Overview Piu Wong  Labeling, Label, and Language: A Truly Global Matter Evangeline D. Loh and Jaap L. Laufer  Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific Seow Li-Ping Geraldine  Medical Device Classification Guide Patricia Teysseyre  ISO 13485:2003/2016—Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes Gert Bos ISO 14971: Application of Risk Tony Chan and Raymond K. Y. Tong  Medical Devices: IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance Gabriela Ehrlich  Introduction of Good Submission Practice Isao Sasaki  United States Medical Device Regulatory Framework James Bertram  Regulation of Combination Products in the United States John Barlow Weiner and Thinh X. Nguyen  European Union: Medical Device Regulatory System Arkan Zwick  Regulation of Combination Products in the European Union Janine Jamieson and Elizabeth Baker  Medical Device Regulatory Affairs in Latin America Carolina Cera and Gladys Servia  Saudi Arabia: Medical Device Regulation System Ali Aldalaan  Australian Medical Device Regulations: An Overview Petahn McKenna  China: Medical Device Regulatory System Jean Zhang  Hong Kong: Medical Device Regulatory System Jack Wong and Linda Chan  India: Medical Device Regulatory System Kulwant S. Saini  Indonesia: Medical Device Regulatory System Mita Rosalina  Japan: Medical Device Regulatory System Atsushi Tamura  Korea: Medical Device Regulatory System Malaysia: Medical Device Regulatory System  Yew Siak Wah  Philippines: Medical Device Regulatory and Licensing Mitzumi F. Duclayan, Mary Claire Cacanindin, and Jennifer Cheah  Singapore: Medical Device Regulatory System Annie Goh  Taiwan: Medical Device Regulatory System Introduction Pei-Weng Tu  Thailand: Regulatory and Medical Device Control Yuwadee Patanawong and Nachsupol Arunaramamporn  Vietnam: Medical Device Regulatory System Nguyễn Minh Tuấn, Le Thu Nga  A Strong Regulatory Strategy is a Competitive Advantage to a Medical Device Company Jacky Devergne