As 2019 draws to a close without the achievement of several hoped-for advances in regulatory procedures for medical devices, multinational companies in the sector are looking to the new year for some significant breakthroughs. Topping the wish list is passage of the draft Medical Devices Act, which would create dedicated legislation to govern the industry…

Most of AmCham Taipei’s member companies in the medical device field are sales and marketing arms of the world’s major multinational, especially American, brands. The profiles below introduce two member companies that are exceptions in that their forte is manufacturing, with Taiwan as their main base. As private companies they don’t disclose their financial information,…

Taiwan should adopt the MDSAP multilateral approach to plant audit reports. In this year’s Taiwan White Paper, AmCham Taipei’s Medical Devices Committee called attention to problems arising from Taiwan’s documentary requirements for medical device companies to qualify to utilize the government’s simplified approach to auditing manufacturing facilities in the United States. As part of the…

Taiwan has one of the world’s most efficient, accessible, and effective healthcare systems, offering quality care at affordable prices. Yet despite this success, the rapid aging of Taiwan’s population is presenting an unprecedented challenge to Taiwan’s National Health Insurance (NHI) system. According to the National Development Council, this year 14% of Taiwan’s population will be…

This is a special supplement to the December 2016 issue of Taiwan Business TOPICS, sponsored by the AmCham Taipei Medical Devices Committee. The full PDF document is available for download here. Table of Contents:  Preface, Challenges and Opportunities The Value of Technology Streamlining the Medical Device Registration Process Referencing Japan Strengthening the Pricing and Reimbursement…