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. 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.

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.

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 Nguy-n Minh Tün, Le Thu Nga A Strong Regulatory Strategy is a Competitive Advantage to a Medical Device Company Jacky Devergne