2nd Edition
Handbook of Medical Device Regulatory Affairs in Asia Second Edition
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.
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
Biography
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.
