Publications on China

China Medical Device GMP Regulations Update

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.

Device Manufacturers in China Face Increased Regulatory Scrutiny

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.

Chinese Pharmaceutical Regulatory Report 2010

This report includes a brief overview of the pharmaceutical and healthcare industry in China, as well as a discussion of all the relevant laws and regulations that govern the testing, registration, manufacture, import, marketing, and sale of pharmaceutical products. Specific topics include: product registration, pricing and reimbursement, importation, GMP, GCP, orphan drugs, and intellectual property protection. The appendix contains a full translation of the revised Administrative Provisions for Drug Registration, the recent overhaul of China's drug regulations. It also contains the annexes to this document detailing dossier submission requirements, all up-to-date.

Chinese Pharmaceutical Market Report 2010

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. It also includes three appendices: one on recent acquisitions, ventures, and partnerships in the Chinese drug industry; a list of all drugs which Chinese government health insurance will reimburse; and contact information for key Chinese drug agencies.

Quality Assurance for Medical Devices in China Webcast

More and more medical device companies are sourcing and manufacturing their products in China. However, given recent problems with heparin, di-ethylene glycol and melamine poisoning, quality issues have become paramount. What do you need to know about QA in China to be successful and avoid pitfalls? This webcast will go over the latest regulations for medical device QA, GMP, adverse event reporting, and additional plans for quality control. A Chinese case audit will help emphasize key issues.

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

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

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.

How Medical Companies Can Be Successful Webcast

There is no doubt that China is and will continue to be a global hotspot for the medical industry. Yet many Western companies that rush haphazardly into China without fully understanding its business culture and mentality ultimately meet with failure. This webcast presentation first provides crucial information on entering the Chinese market. It then goes one step further to give insight into communication and management techniques that have proven effective in the Chinese business context.

China Medical Device Regulatory Update

China’s 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, 2007 saw many quality control problems with recalls and scandals. To be successful in this fast growing market, buy this webcast CD 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.

Changing Business Practices in the Chinese Pharmaceutical Market

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.

Entering China's Expanding Medical Device Market Webcast

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. However, 2007 saw many 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.

Business and Marketing Strategy for China's Pharmaceutical Market Webcast

Do you know what it takes to succeed in today's ever evolving China pharmaceutical market? What are profitable foreign and domestic drug companies doing in China to maximize growth and increase sales? What are the current market trends and how can you apply these effectively for your company? China is the ninth largest pharmaceutical market in the world, worth approximately $20 billion. Buy a webcast CD today, before it's too late, to learn more about marketing and selling effectively and developing your high-return business strategy.

Updates on China's Medical Device Market Webcast

The recent crackdown by the SFDA has meant new regulations and stricter enforcement for all aspects of the Chinese medical device market. Make sure you know of all the recent regulatory changes in China and the SFDA’s plan for the future. This webcast CD will cover dossier preparation and product registration processes in addition to recent new Chinese medical device regulations.

Chinese Manufacturing: Scandals and Opportunities

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.

China Product Registration and Regulatory Issues Webcast

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).

Drug Registration and Other Regulatory Issues in China

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

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.

GMP and QA for Medical Devices in China Webcast

This webcast provides an overview of China's current Quality Certification systems, Good Manufacturing Practices, and Vigilance, as well as discuss the most recent regulatory issues.  Topics covered include new SFDA regulations, supervision inspections, penalities for non-compliance, and quality system audits.

Medical Device Regulatory Update: China and Japan

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.

Sourcing Medical Devices from China (PDF)

Sourcing Medical Devices from China discusses how companies can successfully source medical devices from China. This presentation includes discussion of key steps in the sourcing process, including establishing initial communications, due diligence, contract negotiations and important contract terms to include when transferring technology, market research, choosing the right distributor, and important cultural considerations when doing business with the Chinese. Also included is brief overview information of the Asian medical device and orthopedic markets.

Opportunities in the Chinese Medical Device Markets (PDF)

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.

China Medical Device Regulations Webcast

This webcast provides an overview of the medical device regulations of the Chinese State Food and Drug Administration (SFDA) as well as discuss the most recent regulatory issues.  Topics covered include a number of new SFDA regulations, pitfalls to avoid, and strategies for a successful product registration.

Dragon & Tiger - Emerging Power of India & China in the Pharmaceutical Industry (PDF)

As China and India continue to improve their pharmaceutical regulatory environments through the implementation of new and stricter regulations, an increased number of foreign companies are entering these markets. This presentation provides information on sourcing medical products in China and India, including how to identify product manufactures, communication issues, pricing, contract negotiations and due diligence. Outsourcing strategies are also described, such as outsourcing clinical trials and R&D, and numerous company examples are given. This presentation also reviews the various types of business structure options in China and India, such as a representative office, branch office, and joint venture.

How to Do Business in China (PDF)

China’s rapidly growing medical market is attracting more and more U.S. companies. This presentation provides information on distributor searches, contract manufacturing, and establishing offices in China. Strategies are provided to help identify, communicate with, and secure contracts with manufacturers in China. Types of Chinese business structures, including equity joint ventures (EJVs), cooperative joint ventures (CJVs), and wholly foreign-owned enterprises (WFOEs), are described, as well as basic recruiting trends and strategies. Finally, Chinese cultural issues and considerations are introduced in order to aid U.S. companies in their Chinese business dealings.

China’s Medical Device Market: 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

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

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.

China Medical Device Regulations 2004 (PDF)

With a steady increase in foreign trade over the past twenty years and entry into the World Trade Organization, China offers many new opportunities for medical product companies. This article provides incite for foreign companies entering China’s medical product market, including information on finding distributors in China. Several options for Chinese distributors are available: Chinese state-owned distribution companies, namely foreign trading companies (FTC) and industrial trading companies (ITC), privately owned trading companies, and Hong Kong distributors. Additionally, information on foreign investment enterprises (FIE), including Equity Joint Ventures (EJV), Contractual Joint Ventures (CJV), and Wholly Foreign-Owned Enterprises (WFOE) is provided.

Entering China's Medical Marketplace

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

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

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

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

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.

Regulatory Trends in China’s Pharmaceutical Market

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

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.

China Market Entry Strategies

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.

Opportunities in the China Biotech Market

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.

American Medical Product Manufacturers Travel Different Roads to China

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

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

This article is a general overview of the many opportunities available for foreign device manufacturers interested in entering China’s medical device market. Key topics include the current healthcare system and its basic features, market entry strategies and business relationships in China. Although Western medical imports have been limited in the past, increasing economic growth and more affluent patients are leading to a greater demand in improved healthcare and modern foreign medical technology. As a result, medical device imports are expected to grow at least 8% per year, providing huge potential in China’s healthcare market for foreign manufacturers.