Handbook of Medical Device Regulatory Affairs in Asia Free Download medical pdf

Handbook of Medical Device Regulatory Affairs in Asia

Medical Device Regulatory Affairs Features

Covers medical device regulatory system in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application
Provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs
Presents contributions from authors working in international regulatory organizations.

Medical Device Regulatory Affairs in Asia Free Download medical pdf

Summary Medical Device Regulatory Affairs

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 Medical Device Regulatory Affairs

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.




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