Handbook of Medical Device Regulatory Affairs in Asia: Second Edition, 2nd Edition (e-Book) book cover

Handbook of Medical Device Regulatory Affairs in Asia

Second Edition, 2nd Edition

Edited by Jack Wong, Raymond Tong

Jenny Stanford Publishing

620 pages | 102 B/W Illus.

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pub: 2018-04-20
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Description

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.

Table of Contents

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

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
MED000000
MEDICAL / General
MED002000
MEDICAL / Administration
MED009000
MEDICAL / Biotechnology
TEC021000
TECHNOLOGY & ENGINEERING / Material Science