Publications on Taiwan
A Regulatory Update on Asia's Smaller Medical Device Markets
Published by MPO
When medical companies think of bringing their products to the Asian markets, they typically think of larger countries like China, Japan, or Korea first. However, other smaller Asian countries such as Singapore and Malaysia can be worthwhile destinations as well. Although they have smaller populations, these markets all have well-developed healthcare systems and are receptive to advanced products. In addition, their medical device markets are growing rapidly and, in many instances, are more easily accessible to foreign manufacturers. Before venturing into these territories, however, regulatory professionals will need to keep track of current changes to be successful. This article discusses recent regulatory developments in Singapore, Malaysia, Hong Kong, the Philippines, and Taiwan.
Updates on Taiwan's Medical Device Market
Presented in the Pacific Bridge Medical Webcast
$400 | Buy Webcast
Taiwan’s medical device market is Asia’s fourth largest at $1.5 billion. Navigating this growing market can be difficult with new regulations on product registration. Topics covered include an overview of Taiwan's healthcare system, product registration requirements, new medical device regulations, and strategies for how to expedite the registration process.
Taiwan Medical Device Regulations Presentation
Presented in the Pacific Bridge Medical Webcast
$400 | Buy Presentation
This presentation provides an overview of Taiwan's medical device regulations as well as discuss the most recent regulatory issues. Topics covered include an overview of Taiwan's healthcare system, product registration requirements, new medical device regulations, and strategies for how to expedite the registration process.
Drug and Device Markets throughout the Asian Region (PDF)
Presented at the Orange County Regulatory Affairs Discussion Group
Pharmaceutical and medical device markets are expanding throughout Asia. This presentation covers the medical device and pharmaceutical markets in Taiwan, Hong Kong, Malaysia, Singapore, India and Vietnam, and provides country-specific information about drug, device and IVD regulations in these countries. Specific topics include registration, pricing and reimbursement, manufacturing and GMP, import licenses, patents, and clinical trials in these countries.
Medical Device Reimbursement in Taiwan
Published by Pacific Bridge Medical
Taiwan’s National Health Insurance (NHI) Program was established in 1995 in order to provide affordable, good quality health coverage to all citizens. Previously, three different insurance systems were in effect, offering nearly a dozen different insurance programs. These programs were only available to labor, government, and agricultural workers and in total, only about 60 percent of the country’s total population was covered by health insurance. Today, the NHI, which is overseen by Taiwan’s Department of Health (DOH), is a mandatory insurance system. All Taiwanese citizens are required to join the program; foreigners with Taiwan resident permits and their dependents are also eligible for enrollment.
Taiwan: An Update for Medical Device Product Registration
Published by Pacific Bridge Medical
Taiwan’s medical device market is one of the most advanced in Asia and it continues to be increasingly sophisticated. The market is worth nearly $900 million, making it Asia’s 4th largest. Taiwan’s domestic industry is growing, but it remains largely fragmented and export-oriented. Nearly 80% of the Taiwanese medical market is made up of imports, with the U.S. contributing more than 30% of that figure.
Overview of Asia, Healthcare Markets and Regulatory Issues in the Region
Presentation at Regulatory Affairs Professional Society (RAPS) Conference
Despite sluggish economies in some countries, Asia still represents future growth opportunities in healthcare products. Over the next 20 years, Asian healthcare markets are expected to grow at a rate two and a half times that of the West. A rising standard of living throughout the region means patients will have the resources to acquire modern medical devices and pharmaceuticals. As the globalization of healthcare continues, regulatory practices for pharmaceuticals and medical devices will be further harmonized. This report examines emerging regulatory trends and issues in China, Japan, Hong Kong, India, Indonesia, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand.
Taiwan: New Pharmaceutical Regulatory Trends
Published by Pacific Bridge Medical
While many countries are experiencing significant increases in medical costs, Taiwan has kept its healthcare expenditures to a minimum and is still able to provide services to over 96% of its citizens. Additionally, Taiwan’s Department of Health (DOH) is working to promote a regulation and review process for pharmaceutical companies trying to enter the Taiwanese market. This article explains how the New Pharmaceutical Processes, Good Clinical Practices (GCP), Adverse Reaction reporting system, Good Manufacturing Practices, and Deregulation of Clinical and Related Trial Rules will help open up the Taiwanese market to foreign drug manufacturers. Moreover, DOH officials and representatives from the Pharmaceutical and Research Manufacturers of America (PhRMA) have established agreements to increase cooperation in the manufacturing of foreign drug products.
Product Registration in Taiwan
Published by Pacific Bridge Medical
As of 1995, U.S. medical manufacturers held about 40% of Taiwan’s import market and that number will continue increase as Taiwan expands its medical technology market. Currently, the Department of Health (DOH) oversees all national health policies, formulates new programs, and manages and coordinates all healthcare services. In addition, the DOH is responsible for all device registration regulations, including implementing the Good Manufacturing Practice (GMP) guidelines and reviewing Plant Master Files (PMF) for all imported products. Moreover, the DOH is looking to fortify its intellectual property laws to protect foreign companies. These issues are discussed, along with specific advice on how to register and obtain a license for medical devices and pharmaceuticals in Taiwan.
Taiwan’s New Universal Health Insurance Program
Published by Pacific Bridge Medical
In Asia, health problems like cancer, heart disease, and automobile accidents are beginning to become the major causes of death, rather than infectious diseases. This major shift in health problems has pressed Taiwan’s government to improve its healthcare system. Previously, Taiwan had a partial insurance system, which left almost 8 million people uninsured. The new National Health Insurance Program (NHI), introduced by the Bureau of National Health Insurance (BNHI) under the Department of Health (DOH), was designed to make affordable, high-quality health coverage available to all of Taiwan’s citizens. This article examines some of the key features of the new NHI program, including its medical services, enrollment, premiums and medical expense payment methods.
Opportunities in the Taiwanese Medical Market
Published in Clinica, a publication of PJB Publications, Ltd.
This article gives a general overview of the Taiwanese medical market, explaining the healthcare system, medical device market, and the main functions of the country’s medical system. The Board of Foreign Trade (BOFT) in the Ministry of Economic Affairs, the National Bureau of Standards (NBS), the Nuclear Science Council, and the National Health Administration are some of the agencies responsible for importing medical equipment. Since heart disease has become a leading cause of death in Taiwan, the opportunity for importing cardiology/cardiovascular medical devices in Taiwan is tremendous. There are many more opportunities for foreign medical device manufacturers as long as Taiwan continues to have a favorable environment for medical device imports.
Blog/RSS