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 requires soft skills for dealing with various key stakeholders in the government, testing centers, hospitals, and doctors.
This handbook is the first of its kind and covers medical device regulatory system in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs. The handbook presents contributions from authors working with regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency (MHRA), Japan Pharmaceuticals and Medical Devices Agency (PMDA), Saudi Food and Drug Authority (SFDA), Korea Testing Laboratory (KTL), Taiwan FDA, World Health Organization (WHO), Asian Harmonization Working Party (AHWP), Regulatory Affairs Professionals Society (RAPS), and British Standards Institution (BSI). Government bodies will find this book immensely useful to understand the global regulatory environment. The medical device industry can use it to better understand and access the Asian market. Academics and students will find it very useful for their research and development projects, and it will ensure that the product developed by them adheres to the global regulatory environment.
"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. The contacts listed in the chapters are valuable and will lead readers to have their first approach in understanding the dynamic process involved in regulatory affairs. This book is the first attempt to bring together the many regulatory bodies on one platform."~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 begins by providing a solid background to concepts such as device classification, clinical trials, and labeling. Detailed information is then provided for each country. 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
“Handbook of Medical Device Regulatory Affairs in Asia 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: Middle East, Australia, China, Hong Kong, India, Indonesia, Japan, Jordan, Republic of Korea, Malaysia, Philippines, Saudi Arabia, Singapore, Taiwan, Thailand, UAE and Vietnam.”~The Journal of Clinical Research Best Practices