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. 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.

Preface on regulatory knowledge needsARPA – 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 : IntroductionHow 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 MCIPart 2: Medical device safety and related ISO StandardsMedical 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 TechnologyRegulatory Affairs for Medical Device Clinical Trials in Asia Pacific - Geraldine SeowMedical Device Classification Guide - Patricia TeysseyreISO 13485 – Gert Bos (BSI - British Standard Institute)ISO 14971 – Prof Raymond Tong and Prof Tony Chan Part 3: Harmonization of Medical Device in AsiaWHO – Adriana Peeling (WHO)AHWP – AHWP chair- Saudi ArabiaAPEC – Ms. Lindsay Tao ASEAN – Ms. Petahn McKenna RAPS – Sherry KeramidasExpediting Innovation in Singapore with Regulatory Knowledge Patricia Ho and Dr. Jui Lim Singapore Stanford BiodesignPart 4: US and EU Regulatory systemUS – 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 CountriesAustralia – Ms. Petahn McKennaChina – Mr Wang Boating (China SFDA), Dr Zheng YiMan, Ms Carol YanHong Kong – Prof Jack WongIndia - Dr Saini KulwantIndonesia - Ms. Mita RosalinaJapan - 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 YeanTingPhilippines – Jennifer Cheah, Mary-Claire CacanindinSaudi Arabia - Ali M. Al Dalaan (Saudi FDA- Saudi Arabia Food and Drug Administration)Singapore – Ms. Lee Ching HweeTaiwan – Ms Liu Li Ling (TaiwanFDA – Taiwan Food and Drug Administration)Thailand – Jennifer Cheah, Eiamsukawat, SwairinUnited 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.