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.
Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.
Table of Contents
Preface on regulatory knowledge needs
ARPA – Prof Jack Wong (ARPA – Asia Regulatory Professional Association)
How to train University students with regulatory - Prof Raymond Tong (HKPU - Hong Kong Polytechnic University)
Part 1 : Introduction
How to be a good regulatory staff - Minnie Baylor-Henry
How regulatory staff works with marketing and supply chain team to ensure smooth product launch – Mr Alok Mishra
Do the right thing – Prof Jack Wong (ARPA – Asia Regulatory Professional Association)
Access of medical device in developing countries – Rosanna Peeling (University of London) and Tikki Pang (WHO – World Health Organization)
"Soft Skills" a story of attention – Richard Liu Account Manager MCI
Part 2: Medical device safety and related ISO Standards
Medical Device History – Dr Bill Wong (MIT – Massachusetts Institute of Technology)
Labeling: why it is so important- Jaap Laufer MD, PharmD Global Head, Regulatory Affairs, DEKRA Certification B.V.; Evangeline D. Loh, PhD, Director Regualtory Affairs, Emergogroup Inc
Clinical Trials: Legal and Ethical Considerations of Increasing Globalization - Paula Celine Trepman, Undergraduate student and researcher, Massachusetts Institute of Technology
Regulatory Affairs for Medical Device Clinical Trials in Asia Pacific - Geraldine Seow
Medical Device Classification Guide - Patricia Teysseyre
ISO 13485 – Gert Bos (BSI - British Standard Institute)
ISO 14971 – Prof Raymond Tong and Prof Tony Chan
Part 3: Harmonization of Medical Device in Asia
WHO – Adriana Peeling (WHO)
AHWP – AHWP chair- Saudi Arabia
APEC – Ms. Lindsay Tao
ASEAN – Ms. Petahn McKenna
RAPS – Sherry Keramidas
Expediting Innovation in Singapore with Regulatory Knowledge Patricia Ho and Dr. Jui Lim Singapore Stanford Biodesign
Part 4: US and EU Regulatory system
US – Ms Carole Carey (US FDA - Food and Drug Administration)
EU – Ms. Patricia Teysseyre
Combination product regulatory in US – John Barlow Weiner (US FDA - Food and Drug Administration)
Combination product regulatory in UK – Janine Jamieson (UK MHRA - Medicines and Healthcare products Regulatory Agency)
Part 5: Regulation in Asia-Pacific Countries
Australia – Ms. Petahn McKenna
China – Mr Wang Boating (China SFDA), Dr Zheng YiMan, Ms Carol Yan
Hong Kong – Prof Jack Wong
India - Dr Saini Kulwant
Indonesia - Ms. Mita Rosalina
Japan - Dr Atsushi Tamura (PMDA - Pharmaceuticals and Medical Devices Agency)
Jordan - Anan Abu Hassan (Jordan FDA)
Korea – Mr Lee (KTL – Korean Testing Laboratories), Ms. Hwang Sun Bin
Malaysia – Ms. Ong YeanTing
Philippines – Jennifer Cheah, Mary-Claire Cacanindin
Saudi Arabia - Ali M. Al Dalaan (Saudi FDA- Saudi Arabia Food and Drug Administration)
Singapore – Ms. Lee Ching Hwee
Taiwan – Ms Liu Li Ling (TaiwanFDA – Taiwan Food and Drug Administration)
Thailand – Jennifer Cheah, Eiamsukawat, Swairin
United Arab Emirates - Dr. Amin Hussain Al Amiri (Ministry of Health – Abu Dhabi)
Vietnam – Mr Tuan and Ms. Thuy Nguyen Thi Thu
Jack Wong is the founder of the Asia Regulatory Professional Association (ARPA) and the Asia GRP (Good Regulatory Practice) Research Centre. He has more than 18 years of experience in regulatory affairs, clinical trials, and pharmacovigilence in Asia and possesses good knowledge of medical devices, pharmaceuticals, and nutritional, consumer healthcare, and biological products. Prof. Wong developed the first Asia Regulatory Affairs Certificate course in 2007.
"This is an excellent and comprehensive book for researchers in medical devices, for students who want to get early exposure to safety and efficacy issues, and for marketing/sales personnel who need to know the various institutions that approve regulatory matters for market accessibility."
—Swee-Hin Teoh, PhD, BEng (1st Hon.), Professor in Bioengineering, Nanyang Technology University, Singapore
"While much has been written about US and European medical device regulations, the Asian regulatory picture has remained clouded for most people. This book is an excellent reference for understanding what is required to bring medical devices to market under the many different regulatory systems in this important region. It is a useful tool as companies and innovators are increasingly looking to Asia as not only a new market for existing products but a launching pad for new technologies."
—Mark Holmes, Terumo BCT, Inc., USA
"This is a very interesting book for biomedical engineering students and medical engineers and an important reference for regulatory affairs professionals. The chapters on quality management systems, such as ISO 13485 and ISO 14971, clinical trial guidelines, medical device classification guide, and the formation of the Asian Harmonization Working Party are well written in plain language."
—Dr. Kwok-kwan Chan, Hospital Authority, Hong Kong, Chairman in Biomedical Division (2012–13), Hong Kong Institution of Engineers
"[It] provides extensive information about the medical device regulatory environment in Asia and the Middle East. In addition to overviews of 16 countries, it discusses medical device classification, ISO 13485 and ISO 14971 quality standards, affordable access, medical device harmonization initiatives in Asia, and other topics of both regional and global interest. The second half of the book reviews the regulatory systems for the following countries: Australia, China, Hong Kong, India, Indonesia, Japan, Jordan, Republic of Korea, Malaysia, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, UAE and Vietnam."
—Norman M. Goldfarb, Managing Director, First Clinical Research in Journal of Clinical Research Best Practices