Publications : Taiwan

Pacific Bridge Medical has published numerous articles in leading trade journals pertaining to the rapidly growing medical market in Taiwan. Our consultants and researchers are constantly identifying pertinent new medical device and pharmaceutical regulations, trends, and other information. The published articles, reports, and webcasts below are free or for purchase.

Taiwan's Medical Device Market: Growth Prospects in 2013

By: Ames Gross and Catherine Matacic
February 14, 2013
Taiwan might be an economic lightweight compared to its mainland cousin, but in the medical device market, the island nation of 23.3 million makes up for its small size. It has a medical device market of $2.5 billion, the fifth-largest in Asia. Taiwans rapidly aging population, high per capita GDP ($21,000) and high rates of healthcare spending make it an attractive market for foreign medical device companies.

2010 Taiwan Drug Registration and Regulatory Issues

June 9, 2010$400    Buy CD
Pacific Bridge Medical presents Taiwan Drug Registration and Regulatory Issues, a 2010 webcast/webinar with an overview of the pharmaceutical industry in Taiwan and the drug registration process.

2008 Managing Asian Cultural/Business Diversity

October 23, 2008$400    Buy CD
Pacific Bridge Medical presents Managing Asian Cultural/Business Diversity, a 2008 webcast/webinar on cross-cultural issues for Western companies doing business in Asia.

A Regulatory Update on Asia's Smaller Medical Device Markets

By: Ames Gross and Momoko Hirose
March 1, 2008
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.

Sourcing Medical Devices in Asia: An Introduction

By: Ames Gross and John Minot
November 1, 2007
This report helps medical device manufacturers and distributors better understand how to source from Asia. Topics covered include: how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, and other issues related to the sourcing equation. This report will also offer advice on how to avoid and troubleshoot problems and pitfalls that may arise in the course of the sourcing process, as well as information about insurance, payment arrangements, freight forwarding, and customs. Furthermore, we will include Microsoft Excel spreadsheet templates on CD-ROM with this report that will facilitate your transportation and shipping decisions when dealing with multiple SKUs being shipped in one container.

2007 Update on Taiwan's Medical Device Markets

June 13, 2007$400    Buy CD
Pacific Bridge Medical presents Update on Taiwan's Medical Device Markets, a 2007 webcast/webinar with information on registration requirements and regulations for medical devices in Taiwan.

2006 Taiwan Medical Device Regulations

April 1, 2006$400    Buy CD
Pacific Bridge Medical presents Taiwan Medical Device Regulations, a 2006 webcast/webinar on Taiwan's medical device regulations, including product registration, changes in regulatory bodies, reimbursement, GMP, QSD, and GCP.

Drug and Device Markets throughout the Asian Region

By: Ames Gross
October 1, 2005
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.

Regulatory Updates for Medical Devices in Asia

By: Ames Gross
June 1, 2005
This presentation provides information on the medical device regulatory environments for Japan, China, Taiwan, Hong Kong, Korea, Malaysia, Singapore, the Philippines, and India. Some of the specific topics covered include Japans new Pharmaceutical Affairs Law (PAL) and Marketing Authorization Holder (MAH) System; the medical device registration process in China; and the reimbursement process in Taiwan.

Medical Device Reimbursement in Taiwan

By: Ames Gross and Rachel Weintraub
May 1, 2005
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

By: Ames Gross
January 1, 2005
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

By: Ames Gross
August 1, 2001
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

By: Ames Gross
March 1, 2000
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.

Asia After the Crisis: Prospects for Foreign Medical Device Companies

By: Ames Gross and Gayatri B. Koolwal
July 1, 1999
Recovering economies throughout Asia offer promising markets for foreign medical device firms as well as opportunities for local product development and manufacturing. Before the Asian financial crisis, regional medical device markets grew at double-digit rates. Patients wanted the technologically innovative, cost-effective devices that foreign medical manufactures could provide. Many Asian countries became dependent on imports. Those factors strong demand and lack of domestic competition remained after the crisis. Furthermore, currency depreciation made it cheaper to establish local facilities for manufacturing and product development. This article features examinations of Japan, China, Singapore, Taiwan, India, Thailand and Malaysia.

Product Registration in Taiwan

By: Ames Gross
October 1, 1998
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.

Device Manufacturers Shouldn't Write Off Asia

By: Ames Gross and Gayatri B. Koolwal
July 1, 1998
Despite its currency crisis, Asia still offers manufacturers many opportunities. Asia's recent currency crisis has caused some U.S. medical device companies to wonder whether there is still a market for their products and services. Concern has risen that Asians have lost their purchasing power, meaning a decrease in U.S. exports to Asia and an unstable economic environment in which to invest. However, not all manufacturers have fled the region. Several companies feel that the crisis has opened new opportunities for manufacturing in Southeast Asia.

Taiwan's New Universal Health Insurance Program

By: Ames Gross
May 1, 1998
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

By: Ames Gross and Pat Dyson
April 1, 1996
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.

Asian Medical Products Markets Take Aim for an Economic Bull's Eye

By: Ames Gross
October 1, 1993
This article is an overview of business opportunities for medical product manufacturers in the Asia Pacific region. Topics include Japan's import requirements, registration procedures, and the keiretsu system; Chinas slow decentralization of its healthcare system; the market growth of Indonesia, Thailand, Malaysia, Korea, Singapore and Taiwan; and business relationships between Western and Asian partners.

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