Publications : China

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

 

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2014 China Medical Device Regulatory Updates

February 26, 2014$400    Buy CD
China's medical device market has grown to $13 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers registering their products in China has grown exponentially. To be successful in this fast growing market, attend our webcast to learn about the new regulations in China. This webcast will also review ways to expedite registration in China. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.

The In-Vitro Diagnostics Market in China

By: Ames Gross
September 18, 2013
China's in-vitro diagnostics (IVD) market is among the fastest growing in the world, with recent annual growth rates of more than 18 percent. In 2007, China made up just 3 percent of the global IVD market. Today, it makes up 8 percent. If current rates hold, China will be the world's second biggest IVD market by 2017.

Registering your API in China

By: Ames Gross
July 12, 2013
Asia's active pharmaceutical ingredient (API) market is worth more than $32 billion, and it is growing more quickly than any other API market, at a rate of 8 percent annually. From 2007 to 2011, Asia's portion of the world API market went from 24 to 28 percent. It should reach a value of more than $50 billion by 2017. Compared to the rest of Asia, China's API market is expanding at an even faster pace. Through 2017, it is predicted to grow at an annual rate of close to 18 percent. Such a fast rate of growth will make China's API market -- now valued at $7.5 billion -- worth $16 billion by 2017.

Hazard's in Outsourcing: China's Medical Device Market

By: Ames Gross
May 14, 2013
Previously, China was associated primarily with low tech components and disposable medical devices. But over the last five years, Chinese manufacturers have made considerable strides in both medical technology and product quality. High end products like diagnostic imaging technology can now be sourced from China. An increasing number of Chinese factories are ISO 13485 compliant and hold China Good Manufacturing Practices (CGMP) certification. Nevertheless, quality issues can still flare up. Despite their international certifications, some Chinese companies cut corners on compliance. Everything from quality assurance documentation to raw material sourcing, manufacturing processes and record keeping can pose significant problems during an audit.

Pitfalls in China's Medical Device Market

By: Ames Gross
April 22, 2013
Despite a recent drop in economic growth, China's economy is still growing. GDP growth in 2013 is expected to reach 7.3 percent, higher than anywhere in Asia. China's medical device market is currently the sixth largest in the world. If current growth rates hold, it will be worth more than $28 billion by 2020. This would make it bigger than every medical device market except the United States and the European Union. But along with these abundant opportunities come considerable pitfalls. Disloyal employees, counterfeiting and misunderstood negotiations are just a few.

China Regulatory and Market Access Pharmaceutical Report (2013)

By: Pacific Bridge Medical
April 11, 2013$1200    Buy Report
This brand new report covers the best way to register your drug in China and optimize market access to increase sales there. It discusses clinical trials in China, required drug documentation for approval, GCP, GMP, drug pricing, reimbursement, provincial bidding, hospital tenders, etc. This report also includes 17 appendices with application forms for pharmaceutical products, a list of Chinese CROs, the essential and national reimbursement drug lists and more.

China's Changing Hospital Market

By: Ames Gross and Catherine Matacic
February 22, 2013
By the end of 2012, China had more than 22,000 hospitals. In comparison, the US had just 5,700. Apart from hospitals, China has a vast network of medical institutions, including clinics and rural community health centers. Their numbers are rising quickly -- community health centers alone posted an annual growth rate of 35 percent from 2004 to 2010. China's hospital market will continue to grow rapidly. According to a recent report by Deloitte, the country's medical services market is increasing at an 18 percent annual rate. It is projected to reach $500 billion by 2015. This represents a considerable opportunity for foreign medical device companies to increase global product sales.

The Battle Over China's Medical Device Market

By: by Ames Gross and Catherine Matacic
February 5, 2013
Chinas $9 billion medical device market is growing very fast. It is now the sixth largest medical device market in the world, and analysts estimate it will grow between 15 - 20 percent annually over the next five years. The country is an attractive market for foreign medical device manufacturers, who still have an edge in producing and selling sophisticated medical devices. However, local Chinese companies are becoming more and more skilled at manufacturing high and low end medical devices. They also often have an advantage in local marketing and distribution. In the short term, foreign medical device companies may retain their large market shares, but in the next five years, it is anybody's guess who will win the fight for China's medical device market.

Intelligent Access to China's Pharmaceutical Market

By: Ames Gross and Catherine Matacic
January 25, 2013
As profit margins in Western markets plummet, multinational pharmaceutical companies are targeting emerging markets like China for future revenue growth. China is set to become the worlds second-largest pharmaceutical market by 2016. It currently ranks third, with an estimated value of $70 billion and growth prospects as high as 20 percent annually. But before jumping into Chinas lengthy drug registration process, you should be aware of some unique dynamics for market access, and how best to understand them.

China's Tobacco Epidemic: A Breath of Fresh Air for Medical Device Companies

By: Ames Gross and Catherine Matacic
January 8, 2013
As Western countries have witnessed precipitous drops in smoking rates, China has become the new heart of the global tobacco epidemic. Of every cigarette consumed during the past decade, one in three were smoked in China: more than 4.3 million a minute, 6.2 billion a day and just over 2 trillion a year. In 2012, more than 310 million Chinese-- nearly as many as the entire U.S. population-- smoked cigarettes every day. Smoking-related diseases account for just over 11 percent of all deaths in China, more than a million every year. Trends like these have influenced a growth in demand for pulmonary, cardiovascular and diagnostic devices among consumers in China. Companies specializing in these devices would do well to explore their options for sales, distribution and manufacturing in China.

2012 China Medical Device Regulatory Update Webcast

September 27, 2012$400    Buy CD
Pacific Bridge Medical presents China Medical Device Regulatory Updates, a 2012 webcast/webinar with an overview of medical device regulatory issues and the market in China.

2012 China Pharmaceutical Regulatory Updates

January 18, 2012$400    Buy CD
Pacific Bridge Medical presents China Pharmaceutical Regulatory Updates, a 2012 webcast/webinar providing an overview of China's product registration and regulatory requirements for pharmaceutical/drug manufacturers.

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.

China's Healthcare Reforms and Medical Devices

By: Ames Gross
April 1, 2011
China has gained economic strength despite the global recession of 2008-2010. As the world's second-largest economy behind the United States, China's gross domestic product growth of 10.3 percent in 2010 was significantly stronger than Organisation for Economic Cooperation and Development (OECD) countries' average of 3 percent. (Founded in 1961, OECD is an international economic organization based in Paris, France, that includes 34 countries and was created to stimulate economic progress and world trade. For more info, visit www.oecd.org.)

2011 China's Medical Device Regulatory Update

February 23, 2011$400    Buy CD
China's medical device market has grown to $7.5 billion, the second largest in Asia after Japan. The number of foreign medical device manufacturers selling, sourcing, or manufacturing in China has grown exponentially. However, there are still quality control problems with recalls and scandals. To be successful in this fast growing market, attend this webcast to learn more about China's current medical device market and its newest regulations. Make sure you have the right business and regulatory strategy to enter and grow your China business

China's 2011 Healthcare Reform Priorities

February 7, 2011
China continues to distribute the $125 billion of government funds that have been allocated for improving China's healthcare. The priorities for this year will be improving public hospitals and providing better preparation to general practitioners, and healthcare improvements in the countryside.

2011 China's Medical Device Market Update

January 26, 2011$400    Buy CD
Pacific Bridge Medical presents China's Medical Device Market Update, a 2011 webcast/webinar providing an overview of regulatory and market issues for medical devices in China.

China's Hospital Market

By: Ames Gross
January 1, 2011
The hospital industry in China is growing at an extraordinary rate. Thirty percent of the country's 2009 healthcare reform initiatives are earmarked for building new health facilities. In other words, since 2009, the Chinese government has been injecting $37 billion into the hospital industry. This inflow of money into the industry will continue to act as a driver to bolster the hospital industry throughout the next five years.

Updates on China's Medical Device Market

By: Ames Gross
December 1, 2010
China's economic growth has skyrocketed during the last 15 years. In the second quarter of 2010, China's nominal gross domestic product (GDP) of $1.33 trillion surpassed that of Japan, $1.29 trillion. Along with the economic surge, China's healthcare market also is growing. For 2009, China's total healthcare spending was approximately 4.5 percent of GDP. In other words, China spent roughly $220 billion on healthcare in 2009. Healthcare spending in China this year likely will exceed $270 billion. This column will examine China's recent healthcare reforms, key growth sectors and successful trends among medical device companies in the country.

Reimbursement in China

By: Ames Gross
October 1, 2010
The global recession has left medical companies scrambling to find new markets. China's GDP, adjusted for purchasing power parity, is currently second in the world and has surpassed Japan's. Medical companies should focus on this growing market. However, before entering the Chinese market it is essential to investigate the market potential and determine reimbursement for your specific medical product. This article will cover the basics of health care in China and how to determine reimbursement for drugs, medical devices, and in-vitro diagnostics in China.

2010 China Medical Device Updates

April 20, 2010$400    Buy CD
Chinas medical device market has grown to $6 billion, the second largest in Asia after Japan. From 2004 to 2005, the number of foreign medical device manufacturers selling, sourcing, or manufacturing in China has grown exponentially. However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount.

China Medical Device GMP Regulations Updates

By: Ames Gross
April 1, 2010
China's State Food and Drug Administration (SFDA) issued various medical device GMP regulations in December 2009. These regulations include detailed GMP rules for sterile and implantable medical devices and GMP inspection standards for these devices. All of these regulations have been marked as interim and could be subject to change. SFDA also issued notices on standardizing the production quality management systems and supervision and inspection of these devices.

China Pharmaceutical Market Report 2010

By: Ames Gross
January 1, 2010$600    Buy Report
This research report contains key information on multiple important topics of the Chinese pharmaceutical market, including market data, the role of government health insurance reimbursement, government price controls, institutional purchasing practices, differing characteristics and business strategies of domestic and foreign pharmaceutical companies, and more.

Device Manufacturers in China Face Increased Regulatory Scrutiny

By: Ames Gross
November 1, 2009
China's State Food and Drug Administration (SFDA) continues to ramp up plans to improve quality and increase regulations in the medical device arena. After setting up a trial Good Manufacturing Practice (GMP) scheme for sterile and implantable medical devices, SFDA issued the Regulations for Medical Device Manufacturing and Quality Control and Inspection Methods to Regulations for Medical Device Manufacturing and Quality Control to solicit public comments in 2008.

2009 Quality Assurance for Medical Devices in China

October 15, 2009$400    Buy CD
Pacific Bridge Medical presents Quality Assurance for Medical Devices in China, a 2009 webcast/webinar with an overview of quality control issues, GMP and QA for medical devices in China.

Updates on the Medical Device Markets in Japan, China and India

By: Ames Gross and Momoko Hirose
September 1, 2009
In today's global recession, innovation, creativity and resourcefulness are essential. Using these tools to determine the appropriate regulatory strategy for your medical device could decide the success or failure of your product in Asia. This article provides the most recent regulatory updates in Japan, China and India to help gain entry to those markets.

China Drug and Device Regulatory Update 2009

By: Ames Gross and John Minot
June 1, 2009
As the global economic crisis deepens, China is entering a new phase in its development. Its exports, economic growth, and employment levels are all falling. It is, however, important for Western businesses to keep these changes in perspective. China's gross domestic product (GDP) growth over the last fifteen years has been extremely fast, around 8-12 percent annually. In the fourth quarter of 2008, growth fell to about 6.8 percent (at an equivalent annual rate). The current economic slowdown will reduce growth to 4-6 percent, which is still impressive by the standards of Western economies. Therefore, China will remain an important market for Western medical companies in terms of its continued growth and high potential for 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.

Changing Business Practices in the Chinese Pharmaceutical Market

By: Ames Gross and John Minot
April 1, 2008
For pharmaceutical companies in China, today is a very exciting time, but also a highly challenging one. Thanks to a rapidly rising economy (GDP growing over 11% in 2006) and newly prosperous citizens wanting better healthcare, the pharmaceutical market there is growing quickly, at about 15% per year. In 2010, some experts predict that China will be the fifth-largest drug market in the world. However, due to demographic and regulatory changes, the market’s structure and incentives are shifting rapidly. Some Chinese drug manufacturers are going out of business, while others are changing just to survive. Foreign drug companies continue to have many market advantages for their high-end products, but they will also need to move rapidly to keep this position.

Chinese Manufacturing: Scandals and Opportunities

By: Ames Gross and John Minot
December 1, 2007
The People's Republic of China has become the foremost manufacturing center in the world today. Chinese manufacturing output increased from 4% of the global total in 1995 to 10% in 2006. Over the past 15 years, gross domestic product has grown at about 9% per year. With Western companies continuing to flock to China to source or manufacture products, the country is permanently altering the economic landscape.

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 China's Medical Device Market

October 16, 2007$400    Buy CD
Pacific Bridge Medical presents Update on China's Medical Device Market, a 2007 webcast/webinar with information on dossier preparation, registration processes, etc.

2007 China Product Registration and Regulatory Issues

March 27, 2007$400    Buy CD
China's pharmaceutical market is currently ninth largest worldwide and worth approximately $20 billion. With analysts predicting this market to be fifth largest by 2010, one cannot ignore China's potential. This webcast will provide an overview of drug registration in China as well as discuss the most recent regulatory issues of the Chinese State Food and Drug Administration (SFDA).

Product Registration & Other Regulatory Issues in China

By: Ames Gross and Momoko Hirose
February 1, 2007
China is the fastest growing economy in the world today. In 2004, GDP in China grew by 9%, while in 2005 it grew by 9.8%. Analysts predict that China's economy will continue to grow at 8% to 9% per annum through 2010. China's pharmaceutical market is currently the ninth largest worldwide and worth approximately $20 billion. Analysts forecast that China's pharmaceutical market will become the fifth largest in the world by 2010, with the OTC market growing to be the largest in the world within ten years. This article describes the requirements for drug registration, in addition to new regulations and other opportunities for medical companies interested in China.

China GMP and QA for Medical Devices

By: Ames Gross and John Minot
January 1, 2007
China's economy is growing rapidly, and so are standards of production. As its manufacturers continue to develop more sophisticated processes and products, quality standards are increasing dramatically. Medical devices are no exception. China's medical device market has grown to $6 billion, the second largest in Asia after Japan. From 2004 to 2005, the number of device manufacturers grew by thousands. Capacity is growing both for exporting abroad and manufacturing for China's domestic market. More standards, national and industrial, are becoming required. While these standards help Chinese sources achieve higher degrees of quality and standardization, they can also present pitfalls. This article briefly describes device GMP and QA regulations and practices in China, as well as recent and coming changes to the system.

2006 GMP and QA for Medical Devices in China

October 24, 2006$400    Buy CD
Pacific Bridge Medical presents GMP and QA for Medical Devices in China, a 2006 webcast/webinar that includes information on China's Quality Certification systems, Good Manufacturing Practice (GMP), etc.

Medical Device Regulatory Update: China and Japan

By: Ames Gross and Nancy Loh
October 1, 2006
The Asian economy has experienced tremendous GDP growth over the past decade, and is expected to continue at a healthy pace for the next several years. In particular, the medical device market has been growing quite rapidly. More and more companies are going to Asia to sell and manufacture their medical devices. In addition, Asian governments are developing new or more rigorous regulatory regimes to raise the quality of medical devices in their countries to international standards. This article highlights some of the recent regulatory developments for medical devices in China and Japan.

2006 China Medical Device Regulations

February 23, 2006$400    Buy CD
Pacific Bridge Medical presents China Medical Device Regulations, a 2006 webcast/webinar on China's medical device regulations, including product registration, reimbursement, classification, GMP, GCP, and GLP.

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.

China's Medical Device Market: 2005

By: Ames Gross and Rachel Weintraub
March 1, 2005
One of the fastest growing economies in the world today is China, growing at a rate of around 9 percent per year. The country's medical device market is currently worth approximately $3.5 billion. Following China's entry into the World Trade Organization (WTO), the State Food and Drug Administration (SFDA) is making greater efforts to create a better medical device regulatory environment. In August 2004, the SFDA implemented new registration requirements, simplifying the device application and review process. Moreover, exporting to China is becoming easier for foreign companies, and tariffs on most medical devices have been reduced to less than four percent as of January 2005. The US is the leading exporter of medical devices to China, contributing nearly one-third of all China's foreign imports.

China: An Update for Medical Device Product Registration

By: Ames Gross
February 1, 2005
The Chinese medical device market is currently worth about $2.5 billion and it is growing rapidly. Exporting to China is becoming easier and tariffs on most medical devices have been reduced to 3.9% as of January 1, 2005. The U.S. is the leading exporter of medical devices to China, with U.S. products making up 1/3 of all imports. Despite relaxed restrictions, there remain many difficulties in exporting medical devices to China. Local procurement policies, test requirements, protection of intellectual property, restrictions on the types of business activities foreign firms can engage in and complex product registration processes all present potential hurdles to medical device exporters.

Eight Simple Rules for Outsourcing to China

By: Ames Gross and Loren Heinold
January 1, 2005
Outsourcing medical device manufacturing to China has become increasingly attractive in the last several years. China was once seen as an option for producing only relatively simple medical products. Yet, significant improvements in Chinese manufacturers' sophistication, technology, and most importantly, product quality have made China much more popular for medical device OEMs. But popularity does not always guarantee an easy process. Finding the right factory can be challenging. There are eight steps that should be part of any medical device outsourcing project for China.

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.

Entering China's Medical Marketplace

By: Ames Gross
August 1, 2000
Once severely restrictive in practice and economically limited, markets in China are beginning to hold brighter prospects for successful entry by foreign manufacturers and suppliers. Medical product companies looking for product import, distribution and manufacturing opportunities in China will find promise in recent trends including a growing economy, a rising middle class with growing per capita incomes, an increased awareness of the benefits of better healthcare, and China's entry into the World Trade Organization (WTO). Through the discussion of the available business strategies, this article will assist medical product companies in addressing new opportunities in an ancient land.

How Medical Device Companies Can Enter and Expand Their Business in the China Marketplace

By: Ames Gross
July 1, 2000
Currently, China's medical device market is worth about $1.4 billion. As this market continues to grow, more and more foreign medical device companies will look for ways to expand into China. This article discusses business strategies available to these companies setting up or expanding business in China. First, a company should develop a market entry strategy, based on factors such as the demand for the product, future growth, and the time frame to enter the market. Distribution options differ, depending on whether a foreign medical company exports to China, or manufactures devices in China. When exporting to China, a company may choose between the following three options: a China state-owned distribution company, a privately owned trading company, or a Hong Kong distributor. Foreign companies that manufacture in China may use a Foreign Investment Enterprise, including Equity Joint Ventures, Contractual Joint Ventures, and Wholly Owned Foreign Enterprises. Moreover, China's entry into the WTO and the related changes taking place, will also help foreign medical companies establish and expand their businesses in China.

Importing Drugs Into China: An Update

By: Ames Gross
April 1, 2000
China's pharmaceutical market is the second largest in Asia, worth $22.5 billion, and will likely increase upon China's entrance into the WTO. In March 1998, the Chinese government created the State Drug Administration (SDA) to oversee drug importation, improving the enforcement and inspection processes of pharmaceuticals. Since its formation, the SDA has revised several drug importation regulations, including the procedures for obtaining a drug import approval, applying for an import drug license, and making changes to an import license.

China Medical Device Market 2000

By: Ames Gross
January 1, 2000
China’s medical device market is one of the largest in the world, and with China’s accession to the WTO, foreign medical companies have an even greater opportunity to enter this fast-expanding market. As people in China continue to demand better healthcare, the need for advanced medical equipment is growing. This article offers information on entering China’s medical device market, including an example of FONAR Corporation’s (Melville, NY) expansion into this market. Moreover, distribution options are described for companies interested in exporting to China or manufacturing in China. Distribution through Foreign Trading Companies, Industrial Trading Companies, and Foreign Investment Enterprises is discussed.

China Pharmaceutical Update

By: Ames Gross
November 1, 1999
China's pharmaceutical market is booming, and with the formation of the State Drug Administration (SDA) in 1998, enforcement of pharmaceutical regulations has greatly improved. An increase in drug supervision, through stricter punishments for drug research, declaration and registration violations, was implemented by the State Administration for the Supervision and Management of Medicine. In 1999, the Chinese government revised its GMP standards, to improve pharmaceutical production and quality. In addition, this article provides updated information on pharmaceutical patents, over-the-counter and prescription drug classification, insurance, healthcare, and pricing.

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.

Regulatory Trends in China's Pharmaceutical Market

By: Ames Gross
December 1, 1998
With an average growth rate of about 18%-20% per year, China's pharmaceutical market is expected to be the world's largest market by the year 2020. Despite complexities within the Chinese system, including confusion over monitoring and approving certain drugs, and restructuring of provincial and local level pharmaceutical regulatory systems, foreign pharmaceutical companies have great investment opportunities. The Chinese government is working on many market reforms to improve the system. Previously, China's Bureau of Drug Policy and Administration (BDPA) and the State Pharmaceutical Administration of China (SPAC) were both responsible for the majority of regulatory processes. However, the newly created State Drug Administration (SDA) is now responsible for regulatory procedures, eliminating functional overlap and confusion. This article discusses the additional regulatory changes made by the Chinese government, including pricing and reimbursement, classification, registration, clinical testing, and intellectual property rights.

Regulatory Issues in China's Medical Device Market

By: Ames Gross
September 1, 1998
As China's standards of living steadily improves and healthcare access progresses, foreign manufacturers will have ample opportunities to invest in China's growing medical device market. Recent regulatory reforms and market adjustments have greatly improved the medical device regulation procedures. This article highlights the changes in the regulatory processes, including product registration of imported and domestic devices, penalties for violating regulations, product testing requirements, quality system inspection, intellectual property protection and marketing regulations. China's medical device market holds tremendous investment opportunities for foreign device manufacturers as long as foreign companies monitor regulatory changes.

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.

Opportunities in the China Biotechnology Market

By: Ames Gross
February 1, 1995
The Chinese biotech industry is becoming one of Beijing's priorities, as biotechnology becomes one of the world's most dynamic and essential modern technologies. Four types of institutions in China already engage in biotechnology research including Academia Sinica (a think tank), university institutes, medical schools, and specialized production facilities. Additionally, Beijing has implemented the 863 Plan (National High-Tech Research and Development Program) to concentrate specifically on high-tech medicines and vaccines, protein engineering, and gene therapy. As the biotech market in China expands, the government will rely heavily on international imports, technological expertise, and collaboration on research development from Western biotech companies. As a result, foreign companies have ample opportunities to invest in China's quickly growing market. This article provides advice for foreign companies seeking opportunities to penetrate China's biotech market. Also included is an appendix of Chinese foreign investment enterprises.

China Market Entry Strategies

By: Ames Gross
January 1, 1995
There are a myriad of opportunities for foreign companies looking to invest into China, whether in electronics, energy, medical products, telecommunications or various other sectors. This article provides comprehensive information on the variety of methods in which a foreign company can penetrate the Chinese market. First, a foreign company can export products to China via a Hong Kong distributor, which can be quick and easy but may not allow full market penetration. Second, a company can enter the market via a direct channel in China. This method is time consuming but will allow fuller market penetration. Lastly, market entry via a joint venture may be the best option for both parties-Chinese and Western-by allowing full market penetration and control by both parties. Each market entry strategy yields advantages and disadvantages, and each strategy's success will depend on the demand for the firm's product.

American Medical Product Manufacturers Travel Different Roads to China

By: Ames Gross
May 1, 1994
As China becomes the fastest growing economy in the world's fastest growing region, foreign manufacturers are eager to take advantage of China's quickly expanding markets, particularly the medical market. Whether a company decides to enter the market through a Hong Kong distributor, a direct channel in China, or through a Foreign Investment Enterprise (FIE-joint venture), each opportunity offers pluses and minuses. This article serves as a guide for foreign medical device manufacturers who are looking to invest in the dynamic Chinese medical market. Additionally, lists of co-production agreements in China, existing manufacturing medical device joint ventures, different types of Chinese FIEs, and statistics of medical device imports are also mentioned.

China's Healthcare System - Growing and Complex

By: Ames Gross
November 1, 1993
Although China's healthcare system is run by the central government, its slow decentralization is prompting a multitude of changes. Chinese consumers have growing incomes and are looking for more advanced treatments, sometimes preferring Western-style treatments over Chinese traditional medicine. Additionally, hospitals are now able to make independent decisions regarding medical equipment and modern technologies to accommodate the growing demand for modern treatment. However, as the cost of treatment goes up, the uninsured population, over 800 million people, only receive the treatment that they can afford. This article examines the basic features of China's complex healthcare system. Western companies should understand the Chinese healthcare system before investing in this quickly expanding market.

Opportunities in the Chinese Medical Market

By: Ames Gross
April 1, 1993
Opportunities in the Chinese Medical Markets includes a brief overview of the medical markets in China. It also includes discussion of several examples of foreign health services and hospital companies that are operating in China, as well as new policies for Taiwanese doctors and investors operating in China. This presentation also discusses some important points to consider when doing business in China, including marketing your product, choosing a distributor, and successful contract manufacturing in China.

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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