Publications/ Taiwan
 |
| Presented in the Pacific Bridge Medical Webcast |
June 2007 |
| By Pacific Bridge Medical |
|
|
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. |
|
| Presented in the Pacific
Bridge Medical Webcast |
April 2006 |
| By Pacific Bridge Medical |
|
|
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. |
|
|
| Internal Publication |
May 2005 |
| By Ames Gross and Rachel
Weintraub |
| 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. |
| |
| Published by Pacific
Bridge Medical |
January 2005 |
| By Ames Gross |
|
| 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. |
|
|
| Published by Pacific
Bridge Medical |
March 2000 |
| By Ames Gross |
|
| 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. |
|
|
| Published by Pacific
Bridge Medical |
October 1998 |
| By Ames Gross |
|
| 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. |
|
|
| Published by Pacific
Bridge Medical |
May 1998 |
| By Ames Gross |
|
| 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. |
|
|
| Published in Clinica,
a publication of PJB Publications, Ltd. |
April 1996 |
| By Ames Gross and Pat
Dyson |
|
| 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. |
|
Back to Top
|
Asia
China & Hong Kong
India
Indonesia
Japan
Korea
Malaysia
The Philippines
Singapore
Taiwan
Thailand
Vietnam
|
