Publications : Asia

Pacific Bridge Medical has published numerous articles in leading trade journals pertaining to the rapidly growing medical market in Asia. 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.

The Expanding Home Healthcare Market in Asia

By: Ames Gross
May 14, 2014
In Asia, rising patient awareness of homecare and an expanding middle class mean that demand for home healthcare is exploding. The Asian market for home healthcare products and services has a double digit annual growth rate. The Asian healthcare device market segment alone (not including home health services or other products) is expanding especially quickly and will reach $15 billion in 2017, up from $2 billion in 2012.

Sourcing and Manufacturing Medical Devices in Asia 2014

By: Ames Gross
March 14, 2014$750    Buy Report
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.

2014 ASEAN Medical Device Update

By: Ames Gross
February 3, 2014
The ten nations that make up the Association of Southeast Asian Nations (ASEAN) -- Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- together have a population of over 610 million, almost twice the population of the U.S. The ASEAN countries' combined GDP is more than $2.28 trillion, or about 25% the GDP of China. The region had a 2013 GDP growth of around 5.9%, compared with an estimated 2.5% GDP growth in the U.S. and .01% growth in the EU.

Asia's Diagnostic Imaging Market

By: By Ames Gross
July 22, 2013
Asia's diagnostic imaging market is growing faster than in any other global region. It is expanding at an annual rate of 11 percent, compared to just 7 percent in the rest of the world. In 2012, the Asian diagnostic imaging market was worth $8.1 billion of the global $24.1 billion market. Most recent growth has come from ultrasound and X-ray, which lead the market based on sales revenue. Other segments include nuclear medicine imaging, mammography equipment, computed tomography (CT) and MRI. MRI has traditionally had extremely low rates of penetration in Asian countries. However, it is now the quickest growing segment of Asia's diagnostic imaging market.

Medical Device Harmonization in Southeast Asia

By: By Ames Gross
July 18, 2013
Together, the ten countries of the Association of Southeast Asian Nations (ASEAN) have a combined GDP of $2 trillion and a population of more than 600 million. Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Myanmar (Burma), Cambodia, Laos and Vietnam made up the only region of the world to see higher economic growth in 2012 than in 2011. Per capita incomes have gone up from Vietnam to Indonesia, and the middle class is rapidly rising across the region. As the middle class has grown, so has demand for more and better quality medical devices. In 2012, the total value of the ASEAN medical device market was more than $4 billion. This is expected to increase to $8 billion by 2017.

Asian Orthopedics Markets

By: By Ames Gross
June 21, 2013
Demand for orthopedic devices is surging across Asia, as people there become older and wealthier. Sales of knee implants, hip implants, trauma devices and other orthopedic products have experienced double digit growth since the early 2000s. However, although half of the world's elderly population lives in Asia, the region constitutes only one quarter of the global $41 billion orthopedics devices market. This means that foreign orthopedic device companies will find numerous sales opportunities in Asia both now and in the near future.

Korea and China: Two Difficult Markets

By: Ames Gross
April 12, 2013
Across Asia, rapid economic growth has fueled the growth of a new middle class. These people -- from China to India to Indonesia -- are spending more and more money on healthcare. Medical device markets across Asia have posted average growth rates of 15 percent per year since the mid-2000s. While such growth is impressive, barriers to market entry are high. In addition to regulatory barriers, language and cultural barriers abound. This is especially the case in Korea and China.

Asian Diabetes Markets

By: Ames Gross and Catherine Matacic
March 15, 2013
Of the worlds 371 million people diagnosed with diabetes, nearly 200 million live in Asia. According to the International Diabetes Federation (IDF), those numbers are set to climb dramatically. By 2030, it is estimated that 522 million people worldwide will have diabetes, with 300 million of them living in Asia. Already, China, India, Indonesia and Japan rank among the top ten countries with the greatest numbers of diabetics.

Asian Cancer Markets

By: Ames Gross and Catherine Matacic
March 1, 2013
Rates of cancer have risen dramatically in Asia, where more than six million people are diagnosed with the disease every year. That number now accounts for 50 percent of new global cases. According to the World Health Organization (WHO), the occurrence of cancer in India and China is set to climb at a rate of 78 percent from now through 2030. As Asians live longer, they are developing more lifestyle diseases that were previously prevalent primarily in Western countries.

Outsourcing Medical Devices to Asia: Trends and Tips

By: Ames Gross and Catherine Matacic
February 25, 2013
In a globalized world, many international medical device companies choose to source or manufacture their devices in Asia. Relatively low labor costs, low overhead costs and improving technical capabilities are all reasons for making the move. Labor costs have risen significantly in China. However, they are still very low in Vietnam, India and Indonesia. And overhead for rent, utilities, medical device components, raw materials and equipment is often much cheaper. While there are many benefits to Asian sourcing, different cultures, different languages and different business practices can make relationships between Asian and Western companies challenging. Looser protection of IP laws and less stringent adherence to contract terms are also concerns. Picking the right country and the right partner is often the key to success when outsourcing to Asia.

Asia's Growing Market for Cardiovascular Devices

By: Ames Gross and Catherine Matacic
February 25, 2013
Cardiovascular disease is common in Asia, where it is a leading cause of death in countries from Japan to India to China. Of the 17.3 million deaths caused by cardiovascular disease each year, nearly 60 percent occur in Asia, according to the World Health Organization (WHO). These numbers are likely to rise in the near future: as Asians become wealthier, they are exercising less, consuming more "Western style" fast food and smoking more. But a growing focus on the prevention, treatment and diagnosis of cardiovascular disease in Asia has led to a growing demand for cardiovascular medical devices. The Asian market for cardiovascular medical devices was worth more than $11 billion in 2012, with 12 percent annual growth. By 2021, Asias share of the global cardiovascular device market is expected to increase from 30 percent to 40 percent.

Increased Medical Device Regulations for Asia's New Tigers

By: Ames Gross and Catherine Matacic
February 14, 2013
With more than 600 billion people and a combined GDP of $2.3 trillion, the ten nations that make up the Association of Southeast Asian Nations (ASEAN) are already experiencing dramatic economic growth. This is especially true of the medical device market, which in 2012 was worth more than $4 billion -- about one half the size of China's market. Roughly 65 percent of the $4 billion comes from Asia's new tigers: Malaysia, Indonesia and Thailand.

Orphan Drugs in Asia 2013

By: Ames Gross
January 1, 2013$1500    Buy Report
While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety of challenges. This report reviews the orphan drug regulations throughout Asia and discusses various business issues related to orphan drugs in Asia. Lists of approved orphan drugs in Asia and orphan drug associations are also included.

Contract Research Organizations in Asia 2012

By: Ames Gross
April 1, 2012$1500    Buy Report
This report on Asian CROs provides a comprehensive list of clinical research organizations throughout Asia. The countries covered include: Japan, Taiwan, Korea, Singapore, Hong Kong, India, China, Malaysia, Philippines, Indonesia and Thailand. Included for each CRO is the contact information, description of services and comments about the CRO. This report includes an overview of the increasing trend of pharmaceutical companies outsourcing clinical research to CROs in Asia, as well as some recommendations for choosing the right Asian CRO. In addition, this report presents some short overviews of the regulatory procedures required for obtaining government approval to conduct a clinical trial in each of the above countries.

Asia's Growing Medical Device Market

By: Ames Gross
January 5, 2012
Asia is becoming a highly attractive market to Western medical device companies due to its strong economic growth, large population and aging populations. Western medical device companies are encouraged to take advantage of Asia's medical device market.

2011 Strategies for Success in China, Japan, and India

October 12, 2011$400    Buy CD
Pacific Bridge Medical presents Strategies for Success in China, Japan, and India, a 2011 webcast/webinar with information on the key business and regulatory issues for drug and medical device markets in China, Japan, and India.

Cancer Markets in Asia

By: Ames Gross
September 1, 2011
During the last decade, rates of cancer have increased dramatically in Asia. Asia accounts for nearly half of all new cancer cases in the world. Some cancers that are common in Western countries--such as lung, breast, and colorectal cancers--also are common in Asia. Others, such as stomach and liver cancer, are not as widespread in the rest of the world, but frequently diagnosed in Asia.

Diabetes Explosion in Asia

By: Ames Gross and Arthur Chyan
September 1, 2010
Asia's cases of diabetes are at an all-time high. The International Diabetes Federation (IDF) estimates that more than 125 million people in Asia are suffering from the condition this year. These numbers are climbing quickly. There likely will be more than 200 million diabetes sufferers in Asia by as early as 2030. Compared to the rest of the world, Asia's rate of diabetes diagnoses is the highest. Already, India, China, Indonesia, and Japan rank in the top five for countries with greatest numbers of diabetics.

Device Companies Look to Asia for Growth

By: Ames Gross and Momoko Hirose
August 1, 2010
Asia will continue to lead the world's growth over the next 20 years. Whether Western device companies maximize their opportunities in the region will be a function of understanding various regulatory and business issues in the Asian countries.

Medical Device Updates and Regulation Changes in Asia

By: Ames Gross and Momoko Hirose
February 1, 2010
Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries.

Sourcing Medical Devices in Asia 2010

By: Ames Gross
January 1, 2010$750    Buy Report
This report helps medical device manufacturers and distributors better understand how to source from Asia. The report covers topics such as 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.

Looking East for R&D and Clinical Trials

By: Ames Gross and John Minot
May 1, 2009
R&D in Asia has the potential to significantly improve the global performance of medical device companies by cutting costs and speeding product development--but extensive due diligence is required for success.

ASEAN Medical Device Regulatory Integration

By: Ames Gross and John Minot
February 1, 2009
Navigating global regulatory markets can be a challenge, particularly when multiple countries in a region differ in their rules. Playing by a common set of rules for medtech regulation is about to get a little easier in Southeast Asia, as a group of countries prepares to unveil a more unified approach to oversight.

New Medical Device Regulations in Singapore and Hong Kong

By: Ames Gross
February 1, 2009
Hong Kong is now a part of China, but as a special administrative region, Hong Kong has its own medical device regulations separate from China. Having only a few local device manufacturers, Hong Kong imports most of its medical devices. While there has been little legislative control over the import process in the past, recent changes to Hong Kong's medical device registration system suggest that there will be stricter requirements for medical devices in the future.

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.

2008 ASEAN Medical Device Harmonization Trends

September 9, 2008$400    Buy CD
Pacific Bridge Medical presents ASEAN Medical Device Harmonization Trends, a webcast/webinar on the medical device regulatory environment in the Southeast Asian nations, including Indonesia, Malaysia, the Philippines, Singapore, Thailand, and Vietnam.

Updates on Asia's Medical Device Market -- IVD Focus

By: Pacific Bridge Medical
April 28, 2008
Asia is increasingly focusing their regulations on In-Vitro Diagnostic (IVD) devices and reagents. This presentation provides an overview of the major Asian medical device markets while including details on IVD regulations.

Standards in Asia's Medical Device Market

By: Pacific Bridge Medical
March 19, 2008
Asia is increasingly focusing their regulations on harmonization and compliance with international standards in medical devices. This presentation provides an overview of the major Asian medical device markets while including details on specific countries, such as China, Korea, and Japan.

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.

Regulatory Update: Asia's Largest Medical Device Markets

By: Ames Gross and Momoko Hirose
January 1, 2008
Asia's growth over the last five years has been phenomenal. China saw at least 10% annual growth in GDP between 2003 and 2006, and India's GDP figures progressed from 7% to 9% over the same period. These countries' medical device markets are growing at similarly high rates as their populations demand better healthcare to match their new living standards. On the other hand, Japan and Korea, with slower GDP growth (2% in Japan and 5% in Korea in 2006), are also attractive, mature markets for medical devices. This article discusses recent medical device regulatory developments in these major markets.

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.

Conducting Clinical Trials in Asia

By: Ames Gross and Momoko Hirose
March 1, 2007
With steadily increasing drug development costs and significant time spent on clinical trials, outsourcing clinical trials in Asia has rapidly become an appealing option for many firms. As developing a single drug can cost more than $200 million and take at least 10 years, Asia (except Japan) offers a less expensive, less time-consuming process for clinical trials. Simultaneously, increased demand and awareness for various medical drugs and health services have encouraged many of these countries to develop their own Contract Research Organizations (CROs), and many U.S. firms have eagerly turned to these options to survive in a growing competitive global market.

Orphan Drugs in Asia

By: Ames Gross
October 1, 2006
While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety of challenges. This report reviews the orphan drug regulations throughout Asia and discusses various business issues related to orphan drugs in Asia. Lists of approved orphan drugs in Asia and orphan drug associations are also included.

Asia Orthopedics Update

By: Ames Gross and Nancy Loh
May 1, 2006
Asia has a population of over 4 billion people, and represents about 60% of the world's population. Annual economic growth rates in the Asian countries have been as high as 8 or 10% over the past decade, in comparison with some developed countries where growth has been 4% or lower. In many Asian countries, this rapid economic growth has led to increased personal incomes, improved public health care, and longer life expectancies. The Asian market for orthopedic devices today is valued at about $1.5 billion, with average annual growth in recent years of over 5%. Hip implants have the largest share of the market, with over 40%; trauma devices account for about 35%, and knee implants account for about 25%. On a global scale, Asia accounts for about one-quarter of world demand for orthopedic products. The Asian orthopedic device market is forecasted to reach nearly $2 billion in 2009.

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.

Outsourcing Medical Products to Asia

By: Ames Gross and Rachel Weintraub
August 1, 2005
As competition in the global medical device market intensifies, U.S. medical companies are increasingly seeking out ways to reduce costs in manufacturing, R&D, clinical trials and other medical services. Many Asian countries offer a lower cost of labor (China and India) and skilled labor force. Combining this with the region’s fast-growing economies and quickly aging populations (Japan’s elderly population is currently 19.48 percent, versus about 12.5 percent in the U.S.), these conditions provide promising opportunities for U.S. medical device companies outsourcing to Asia.

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.

Pharmaceuticals in Asia: Regulatory and Safety Updates

By: Ames Gross
May 1, 2005
The global pharmaceutical industry is one of the fastest growing markets in the world, worth nearly $550 billion. The Asian region is a major contributor to this market; the pharmaceutical markets in Japan and China alone are worth approximately $80 billion. With an aging population and rising healthcare standards, there is a far greater push for more stringent pharmaceutical laws and safety regulations in the region. This presentation will cover the Asian countries, including Japan, China, Taiwan, Singapore, Malaysia, India and Vietnam.

Regulatory Updates for Drugs, Devices and IVDs in Asia

By: Ames Gross and Rachel Weintraub
May 1, 2005
To expand their sales in the Asian medical markets, medical companies need to stay abreast of the new and changing regulatory environments for drugs, devices and In Vitro Diagnostics (IVDs). New or improved regulations are implemented frequently in Asia, including changes in GMP standards, drug price controls and medical device regulatory systems. This article discusses some of the recent and more significant changes in the region's medical regulations. Countries impacted by these new regulations and covered in this article include Japan, Hong Kong, China, Malaysia, Taiwan and Vietnam.

Outsourcing to Asia

By: Ames Gross
May 1, 2005
This session will investigate manufacturing and subcontract manufacturing in China. Topics to be discussed include how to set up a factory in China and steps to import medical products. Outsourcing R&D and clinical trials with a focus on India will also be covered. - Key considerations when setting up manufacturing in China - The best ways to import medical products from China - Outsourcing opportunities in India

Sales and Marketing of Your Pharmaceutical Products in Asia

By: Ames Gross
May 1, 2005
This presentation provides insightful information on building distributor networks, setting up your own office in Asia, and marketing strategies in the Asian region. Specifically, business structure options for China and Japan are described, as well as some recruiting strategies for staffing offices in these countries. Regulatory information on pharmaceutical promotion, sampling and pricing is included for Singapore, Malaysia, Vietnam, and other countries.

The Lure of Asia: Lower Costs and Much More

By: Ames Gross and Rachel Weintraub
July 1, 2004
With the growth of Asian economies spurring on the expansion of Asian medical markets, medical and pharmaceutical companies in the West are increasingly looking to Asia for outsourcing. Western medical device and pharmaceutical companies have begun to outsource research and development, clinical trials, manufacturing, healthcare services and drug discovery--benefiting from lower costs and increased productivity. A high number of qualified and Western-educated engineers, scientists and technicians, from countries like China and India, are also returning to their home country to work in the growing medical industries. Although there are still small discrepancies with intellectual property (IP) protection, good manufacturing practices (GMPs), and other international standards, Asian countries are working to implement stricter regulations. This article highlights the benefits of Western companies outsourcing to Asian countries such as China, India, and Malaysia.

Asia's Cardiovascular Markets: A Large Opportunity for Medical Companies

By: Ames Gross and Caroline Tran
July 1, 2003
Heart disease continues to be one of the leading causes of death in Asia. As countries like Japan, China, Taiwan and the Philippines have a greater demand for medical devices and pharmaceuticals to help treat cardiovascular disease, many foreign medical companies have entered into the Asian market. Moreover, as many of these Asian countries' governments undergo restructuring and decrease the amount of medical coverage they provide, people are demanding more western products and are willing to pay for them, as they have often been proven more efficient than local products.

Medical Manufacturing in Asia

By: Ames Gross and Caroline Tran
May 1, 2003
Despite the slowing economies, Asia still continues to offer medical device manufacturers many investment opportunities. With information and updates on China, Malaysia, Thailand, the Philippines and ASEAN, this article highlights the benefits and advantages of manufacturing medical devices in Asia. Asian countries offer significant tax exemptions and other investment incentives for manufacturing companies, therefore more and more foreign investors are focusing on Asia. Additionally, the ASEAN Free Trade Area (AFTA) will come into effect in 2003, providing for greater economic efficiency, productivity and competitiveness by eliminating tariff and non-tariff barriers in Asia.

Key Asian Medical Regulatory Issues

By: Ames Gross and Caroline Tran
April 1, 2003
This article covers some of the changing dynamics of the regulatory scene in Asia for pharmaceuticals and medical devices, with information and updates from China, Korea, Japan and Taiwan. Drug prices and reimbursement rates have been cut as governments take steps to control healthcare expenses and shift the burden of drug costs to the people. Product registration and distribution procedures for foreign drug makers are becoming easier in order to attract investment and spur competition. New legislation has created a more transparent process for registering medical devices. Asia holds great promise for medical products as long as companies remain current on regulatory trends.

Device Regulation in Asia: An Update

By: Ames Gross and Caroline Tran
October 1, 2002
Slowing economies have not stopped Asian countries from moving ahead with medical device regulatory reforms. Asian consumers demand high-quality healthcare products, making it worthwhile for American manufactures to be active in the region. Procedures and practices vary according to country. This article highlights developments and offers advice on how to deal with Asian medical regulators, including the Ministry of Health, Labor, and Welfare (MHLW) in Japan, the State Drug Administration (SDA) in China, the Korea Food and Drug Administration (KFDA), the Bureau of Pharmaceutical Affairs and Department of Health (DOH) in Taiwan, and the Health Sciences Authority in Singapore. Topics include procedures for importing, licensing and registering medical devices, good clinical practice (GCP) and good manufacturing practice (GMP) guidelines, clinical trial requirements, and product classification descriptions.

On the Asian Front: For medtech manufacturers, the key to exploiting business opportunities in Asia is an understanding of cultural differences

By: Ames Gross and Shawna Lepage
December 1, 2001
The Asian market as whole is huge, comprising some 3.5 billion people -- 60% of the world total. Each country, though, has its own culture, business norms, and regulations, and companies investing in the region need to be aware of the differences. This article provides information on building an effective distribution network, decision making procedures, the establishment of a joint venture or subsidiary, the art of negotiation, manufacturing practices, and gaining market access through mergers and acquisitions.

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.

Asia: Medical Device Regulatory Issues

By: Ames Gross
September 1, 2000
Regulations for medical devices vary by country in Asia and are always changing. India and Malaysia, which previously did not have regulations for product registration, have recently adopted stricter and more comprehensive guidelines. In Taiwan, where registration rules were different for domestic and foreign products, the process has now been made fairer for foreign companies. The gradual adoption of international standards is taking place in Thailand, where only local standards previously applied. Countries with inadequate or unclear laws, like China, have set up new governing bodies for devices and drugs. Japan also revised its policies. Korea, however, has done little to implement promised reforms. These issues are discussed, with analyses of medical device markets, key regulatory issues, medical device registration requirements, and explanations of national regulatory bodies. Countries include China, Japan, South Korea, Taiwan, and Malaysia.

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.

A Sampling of Medical Device Regulatory Issues in Asia

By: Ames Gross
April 1, 1999
Despite Asia’s short-term economic crisis, Asia will bounce back soon and still be a dominant factor in the 21st century. Similarly, there will be many opportunities for international medical companies in Asia. Before an international medical company can sell its products in Asia, however, unique and difficult regulatory issues will need to be dealt with. This article focuses on four regulatory issues in Japan, Taiwan, and Korea. They are: - Direct versus indirect medical device registration in Japan - Registration and copying medical devices in Taiwan - Medical device registration in Korea - Classifying pharmaceutical products in Japan.

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.

Infectious Disease Diagnosis and Treatment in Southeast Asia

By: Ames Gross and Timothy G. McDonald
April 1, 1998
Southeast Asia is becoming an increasingly important market for medical products, including products for diagnosing and treating infectious diseases. Pharmaceutical and diagnostics firms can take advantage of shorter regulatory procedures required in Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, Singapore, Thailand, and Vietnam by marketing products in these countries before doing so in other Asian nations. Also, early registration in a Southeast Asian country allows companies to collect real world data that can be used to register a product in countries with stricter guidelines, such as Japan. This report focuses on three diseases: HIV/AIDS, malaria, and cholera, and discusses strategies for regulatory approval and production, as well as epidemiology and pathophysiology, diagnosis, pharmacological treatment, vaccines and prevention programs. As HIV/AIDS becomes more prevalent, markets for products will grow. However, continued development and better health standards will lower the occurrence of malaria and cholera, and subsequently reduce demand for products.

Asian AIDS Markets: Growing Opportunities

By: Ames Gross and Alisa DiCaprio
February 1, 1998
The growth rate of HIV and AIDS cases in Asia is the highest in the world. The dynamic nature of the Southeast Asian markets, in conjunction with the rapid spread of HIV and AIDS has spawned a region of incredible potential for diagnostic, therapeutic, and vaccine technologies, as well as related drugs and equipment. Companies that are able to establish a presence in Southeast Asian HIV and AIDS markets will now find a much more hospitable environment. This article discusses the nature of HIV/AIDS in affected countries, including Malaysia, the Philippines, and Thailand, and government prevention policies. There is also information about the market for rapid diagnostic tests and therapeutic products, registration time frames, insurance reimbursement rates, and clinical trials.

Analysis of Asia's Changing Health Care Delivery Systems

By: Ames Gross and Elaine C. Conavay
August 5, 1997
This article contains analyses of healthcare trends and policies, and the role of foreign medical companies in China, Hong Kong, Indonesia, Malaysia, Philippines, Singapore, South Korea, Thailand and Vietnam. As Asia continues to be the fastest growing region in the world, economic and population growths have a profound effect on Asia's healthcare needs. In order to accommodate the demand for better healthcare services, governments are shifting from subsidized and government-run facilities, to private sector facilities. Consequently, this shift takes off some of the burden of healthcare expenditure. Moreover, the standard of living is improving and more middle class patients are demanding better healthcare facilities and sophisticated medical treatment. This demand provides ample opportunity for foreign medical device and pharmaceutical manufacturers to invest in the Asian medical marketplace, as healthcare providers will need to obtain sophisticated products necessary to meet the rising standards.

Asia's Emerging Pharmaceutical Markets: A Look at China, Indonesia, Thailand, the Philippines, and Malaysia

By: Ames Gross
January 6, 1997
Growing healthcare reforms throughout Asia offer optimistic future prospects for multinational pharmaceutical companies. Southeast Asia has the world's fastest growing pharmaceutical market; while China's pharmaceutical sales have reached up to $10 billion and will continue to grow. Despite the issues of intellectual property protection, differing disease needs, chaotic drug distribution, and reimbursement and pricing concerns, foreign pharmaceutical companies are establishing joint ventures and investing millions of dollars into the region's pharmaceutical markets. Some companies who have established joint ventures in China include Bayer, Glaxo Wellcome, and SmithKline Beecham. This article goes over the status of pharmaceutical markets in China, Indonesia, Thailand, the Philippines, and Malaysia. Additional topics include the existing healthcare systems, domestic markets, and the business activity in the region's markets.

U.S. Medical Technology Firms: To Penetrate The Asian Market, Manufacture There

By: Ames Gross and Larry Hewes
January 1, 1997
As Gross Domestic Product (GDP) numbers soar in Asia, governments are eagerly spending more money on health and medical-related devices, further opening up medical markets to international investment. Foreign medical technology firms investing in Asian markets are experiencing rapid success by manufacturing their products in Asia, rather than outside the continent. Most foreign companies have established joint ventures in the region, such as Hewlett-Packard’s Medical Products Group, giving them a competitive edge over companies who manufacture elsewhere. Asian countries often offer special interest rates, tax exemptions, free-trade zones, and export incentives. This article goes over the benefits of manufacturing in Asian countries and includes success stories of joint ventures in the medical equipment and device markets, pharmaceutical markets, and health and personal care product markets.

Personal Relationships Are Key to Finding an Asian Distributor

By: Ames Gross and Laura Mancini
May 1, 1996
This article serves as a comprehensive guide for U.S. medical manufacturers looking to find a distributor in Asia. Topics include checking a distributor’s background, negotiating a distribution agreement, Asian legal systems, exclusive vs. nonexclusive distribution, sales targets, and other responsibilities of the distributor. Since personal relationships are the foundation for a smooth partnership with an Asian distributor, U.S. medical manufacturers should be able to acknowledge the many differences in doing business in Asia, and work with those differences to enjoy great success in the Asian medical markets.

Asia's Aging Population Creates Opportunities for U.S. Firms

By: Ames Gross
January 1, 1996
As medical technologies become more widespread and advanced, multitudes of lives are prolonged by more modern and improved healthcare, particularly in Asia. Asia’s aging population has pushed governments to reform healthcare systems to accommodate this challenge. Subsequently, that has created more business opportunities for foreign medical manufacturers who can specifically address the medical needs of Asia’s elderly. Countries like Singapore, Japan and Malaysia have all opted for privatization, which provides high quality care and shorter wait times, while other countries still emphasize the public sector. This article discusses the aging population situation in Asia and the opportunities that this issue presents for foreign medical device manufacturers.

Asians Aim for the Perfect Smile

By: Ames Gross
November 1, 1994
An exceptional economic boom in the Asia Pacific region has spurred a large expansion in dental markets, providing remarkable prospects for foreign manufacturers of dental equipment. Dental hygiene and cosmetics have become major consumer health priorities as many more consumers can afford additional dental procedures. Japan is Asias largest dental market and even with the National Health Insurance (NHI) scheme covering only acute dental care, patients are willing to pay for many more non-acute dental procedures. Singapore boasts a high-technology dental system, encouraging neighbors from Indonesia, Thailand, Malaysia and the Philippines to come seek dental service. Hong Kong sustains a prosperous import market and plays an important role as the gateway to mainland Chinas dental market. This article highlights the major aspects of these three dental markets in Asia and the potential success for foreign dental equipment manufacturers in the region.

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.

Doing Business in Asia

By: Ames Gross
January 1, 1992
A basic guide to conducting business in China, Japan and Southeast Asia. Topics include personal and business relationships, negotiating, gift-giving, body language, introductions and language and cultural differences.

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