February 17, 2015
The new PMD Act was based on previous ordinances implemented in the summer of 2014. Two of the main points of this revision are to increase safety measures for medical devices and introduce new cellular and tissue therapeutic product regulations.
January 13, 2015
One of the best ways for small and mid sized Western device firms to take advantage of these growing markets is to conclude agreements with reputable, trustworthy, and well connected medical device distributors located there.
October 20, 2014
Japan is a rapidly aging society with one of the highest life expectancies in the world. Today, more than 23% of Japanese -- 30 million people -- are over the age of 65. By 2025, this will jump to 33%. Japan has a purchasing power parity GDP per capita of almost $40,000-- and seniors account for more than half of Japanese consumer spending. Japan's aging, wealthy society offers Western elder care device companies many opportunities.
This Japan drug regulatory PowerPoint presentation covers many basic issues for international drug companies looking to gain more knowledge about the Japanese drug market. It includes information on registering ethical, biological, orphan, and generic drugs in Japan. The presentation also provides information on drug classification, reimbursement, and clinical trials.
September 3, 2014
Finding the right medical executives for your Japan office can be challenging. If you headhunt a Japanese medical executive and the executive turns out to be not as good as you thought, this could lead to problems in your Japan business. For example, if your new medical sales and marketing executive signs up the wrong Japanese distributors, you may have distribution problems.
September 1, 2014
In late June 2014, the Japanese Cabinet approved Prime Minister Shinzo Abes new economic growth strategy. One of the proposed reforms is to deregulate some of Japans highly protected industries -- including healthcare. A key pillar of Abes economic strategy is expanding coverage of mixed medical treatments.
Reform of the Japanese mixed medical treatment system should lead to increased opportunities for Western medical companies in Asias largest healthcare market. An example of a mixed medical treatment would be combining anti-cancer drugs that have not been approved in Japan with approved anti-cancer drugs for patients with late stage cancers. Western companies may soon be able to provide advanced medical products to Japanese patients in many more situations -- without medical device or pharmaceutical product approval in Japan.
Japan is the second largest medical device market in the world. Getting through the registration process and selling your product on the market is not an easy task. This webcast will focus on key steps including PMDA consultation sessions, how to maximize foreign clinical data, and how to expedite product registration. This is a very detailed and informative webcast. The presenter is Ames Gross, president of Pacific Bridge Medical. Mr. Gross has been doing business in Japan for 30 years. There will be a 60-minute presentation followed by a 30-minute Q&A session.
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.
July 12, 2013
The active pharmaceutical ingredient (API) market in Asia is growing at an increasingly rapid pace. From 2007 to 2011, it went from 24.5 to 28.5 percent of the world market. From now through 2017, it should expand at a rate of 8.2 percent annually. This puts Asia's API market -- worth $33 billion currently -- at more than $50 billion by 2017. Japan has long led the rest of Asia in demand for APIs. In 2012, the market for APIs in Japan was the largest in Asia, at $15.5 billion. Many foreign API firms from India, Europe and the US are actively selling their APIs on the Japanese market.
April 4, 2013
The size of the medical device market in Japan is $25.5 billion. This is two and a half times larger than China, making it the biggest medical device market in Asia. But fierce competition, strong demand for high quality products and complex regulations make Japan the most difficult Asian market to enter for foreign medical device companies.
Pacific Bridge Medical presents Japan Business Culture, a 2013 webcast/webinar with an overview of business etiquette and expectations in Japan.
Pacific Bridge Medical presents Japan Medical Device Product Registration and Regulatory Updates, a 2012 webcast/webinar with an overview of medical device regulatory issues and the market in Japan.
August 14, 2012
Foreign medical companies must assign a Market Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH) in Japan in order to sell their products. A DMAH is a company registered by the MHLW that performs market authorization holder services. A DMAH is the market authorization service provider (either a Japanese distributor or an independent third party) located in Japan, that a foreign medical company uses if the company does not have its own office there.
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.
Pacific Bridge Medical presents Japan Medical Device Updates, a 2011 webcast/webinar with an overview of updates for medical device product registration, gmp, quality assurance/QA, reimbursement, and foreign manufacturer accreditation.
Pacific Bridge Medical presents Medical Device Reimbursement in Japan, a 2010 webcast/webinar with an overview of reimbursement for medical devices in Japan.
Pacific Bridge Medical presents Foreign Manufacturer Accreditation for Drugs in Japan, a 2010 webcast/webinar with an overview of Japan's drug accreditation process for foreign manufacturers.
Pacific Bridge Medical presents Japan QMS Audit for Medical Device Registration, a 2010 webcast/webinar with an overview of the QMS auditing process for medical devices to be registered in Japan.
Recently, Western medical device manufacturers have had to comply with Japan's Quality Management System (QMS) standards to register and sell their products in Japan. Pacific Bridge Medical's new report is the only comprehensive English guide to the new Japanese quality audits, including official quality system requirements, documents needed, tips for success, and translations of key Japanese regulations. Help your company pass its PMDA audit the first time with this comprehensive report.
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.
Pacific Bridge Medical presents Updates on Japan's Expanding Medical Device Market, a 2009 webcast/webinar with an overview of the Japanese Medical Device Market.
April 1, 2009
Without a proper understanding of Japan's regulations and cultural differences, companies could fail to get their products registered in that nation. As more and more companies have faced QMS audits, a better understanding of the process has emerged. This article describes several ways to increase your company's chance of achieving compliance.
Pacific Bridge Medical presents Doing Business in Japan, a 2008 webcast/webinar providing strategies and tips for doing business in Japan.
Pacific Bridge Medical presents Managing Asian Cultural/Business Diversity, a 2008 webcast/webinar on cross-cultural issues for Western companies doing business in Asia.
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.
Pacific Bridge Medical presents Japan Audit for Medical Device Registration, a 2007 webcast/webinar with an overview of the QMS auditing process in Japan.
October 1, 2007
Japan's long recession is over. After a frustrating period of starts, stops, and even reverses in economic growth (1990-2002), Japan's GDP growth has stayed near or above 2% since 2003.
With its affluent and aging population, Japan is the second-largest medical market in the world. Over the past ten years, Japan has seen its elderly population rise sharply, with those over 65 years of age increasing from 10% of its total population to over 20%. With a declining overall population, a low birthrate, and a shrinking ratio of productive population to aging population, maintaining adequate healthcare has been a priority of the Japanese government. From 1997 to 2003, government spending on healthcare increased from 6.8% of GDP to approximately 8.0%. Japan remains a key market for medical devices, especially higher-end products, with its medical device market still towering over the rest of Asia's at $25 billion.
Pacific Bridge Medical presents Japan Audit and Accreditation for Foreign Device Manufacturers, a 2006 webcast/webinar providing an overview of Japan's PMDA inspections and accreditation of foreign medical device manufacturers.
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.
PBM presents Japan Medical Device Reimbursement, a webcast/webinar that includes information on Japan's reimbursement system for medical devices, categories, application processes, etc.
PBM presents New Japanese PAL Medical Device Regulations, a webcast/webinar on Japan's medical device PAL regulations.
This report provides a detailed overview of Japan's most recent medical device regulations post April 1, 2005. All new regulatory material cover s issues from April 2005 through January 2006. This report outlines more details on the regulations beyond what was covered in the January 26, 2006 webcast. Specific topics include the new requirements for master file registration, new requirements for applying for a foreign manufacturer certificate, new requirements for GCP compliance review, new post-marketing safety measures, new labeling requirements, and new adverse event reporting requirements, among others.
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.
June 1, 2005
Japanese healthcare standards are among the highest in the world and the Japanese spend close to $300 billion per year on healthcare. Even though this number is far less than the $1.8 trillion spent by the United States every year, Japan’s demand for better and safer healthcare is rising as the country's elderly population continues to increase. Subsequently, the Ministry of Health, Labor and Welfare (MHLW) has become more aware of the need to improve the country's regulatory and safety environment for medical devices.
March 1, 2004
Japan's complex medical marketplace has been significantly deregulated in the past several years. The government has also taken some measures to be more open to foreign businesses, thus allowing more foreign companies to enter Japan's medical market. Several business and regulatory strategies need to be considered so foreign companies can be successful in Japan's marketplace. This article discusses how foreign businesses can find the right consultants, In Country Caretakers (ICCs) and Contract Research Organizations (CROs) to keeps costs and time to a minimum. As of April 2005, the Pharmaceutical Affairs Law (PAL) will require foreign manufacturers to seek one representative to perform regulatory functions, product registration, testing, and sales and marketing.
September 1, 2003
The Asian medical market is facing rapid changes as modernization greatly enhances the development of new and improved medical devices. Japan's recently revised Pharmaceutical Affairs Law (PAL) has maintained its basic purpose since 1948: to guarantee safety, efficiency and quality of medical products in the Japanese market. However, Japanese PAL revisions will also take into consideration the rapidly changing medical products of the 21st century and will bring Japan's medical market up to speed with international standards. The Ministry of Health, Labor and Welfare (MHLW) is reorganizing its main authoritative bodies in order to assist the government's reform efforts. This article examines the additional steps that the MHLW is taking to modify medical device standards.
October 1, 2001
This case study examines the issue of registering medical device products in Japan. The two main components, Company X and Importer Y, are used to demonstrate how a U.S. manufacturer can have direct registration of their medical device products, which allows the manufacturer to have control over its business in Japan, rather than the distributor. Additionally, direct registration allows Company X to appoint multiple distributors, unlike indirect registration.
August 1, 2001
As Asian countries continue to deal with growing elderly populations and the proliferation of heart disease and cancer as leading causes of death, healthcare systems are being revised and new medical device imports are in high demand. Despite Japan's strict regulatory regime for medical devices, the Ministry of Health, Labor, and Welfare (MHLW), has been making efforts to deregulate Japan's medical market. These efforts will accommodate the demand for modern medical devices, including advanced cardiology products, MRI equipment, CT equipment and home healthcare service products. This article talks about Japan's medical device market, focusing on the regulatory environment and deregulation process. It also discusses advertising and promotion, and market entry strategies, with examples of foreign medical companies' strategy success stories in Japan.
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.
July 1, 2000
Clinical trials are essential in monitoring the safety and quality of all pharmaceuticals. Japan's Ministry of Health and Welfare (MHW) and the drug organization (KIKO) are working with the Pharmaceutical and Medical Device Evaluation Center in Japan to guarantee that safety standards, protocol, raw data checks, and consultations with companies are all followed through under the new Good Clinical Practice (GCP) guidelines. The previous Good Clinical Practice standards were vague on the responsibilities of the sponsor, chief investigator, Institutional Review Board (IRB), medical institutions and patients. This article discusses the details of the new GCP requirements and future reforms by the MHW regarding pharmaceuticals.
January 1, 2000
This article is a review of Japan's transforming medical device market. Topics include Japan's medical community, the economy, deregulation issues, pricing and reimbursement, the eldercare market, market entry strategies, and distribution strategies. Figures and statistics are included as guides for each topic. Moreover, accounts of U.S. medical device companies, such as ArthroCare Corporation, Palomar Medical Technologies Inc., and AngioDynamics Inc., and their strategies with Japanese distributors are also included.
January 1, 2000
Japan's medical device market is worth about $23.4 billion and is the second largest in the world, after the U.S. This article goes over some of the key factors in Japan's medical device market, including product registration, reimbursement approval and market entry strategies. Foreign device companies should pay particular attention to information regarding distributors, joint ventures, direct marketing, manufacturing in Japan, and the setting up of offices. These factors are essential for understanding how to successfully enter the Japanese medical device market.
December 1, 1999
Despite the difficulties foreign companies sometimes face when entering the Japanese medical device market, strong demand for more technologically advanced products and sophisticated medical treatment has opened up the market more to manufacturers who can meet this demand. The Japanese government is making an effort to keep rising costs for patients down, as a person can pay up to $2,200 for one year's worth of medical treatment. The government is also aiming to find foreign companies capable of supplying cost-effective advanced medical technology, thus giving foreign medical companies plenty of opportunity to enter the market. However, there are a few issues that hamper entry into the market, including regulatory approval delays and complications. This articles discusses the key issues in Japan's medical device market and the government's reform efforts to address foreign companies' concerns.
September 1, 1999
Recent deregulation reforms within the Japanese pharmaceutical market have been applauded by international pharmaceutical companies and associations alike. Major reform efforts include: withdrawal of the reference pricing system, speeding up the approval process for new drugs, more acceptance of foreign clinical data, increased deregulation of the healthcare sector, and restructuring of the Japanese healthcare system. In addition, the Ministry of Health and Welfare (MHW) is making an attempt to educate physicians, dentists and various other medical personnel through the internet with vital information about new drugs and their effects. This article explains the detailed deregulation efforts made by the government and the effects on the Japanese pharmaceutical market.
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.
May 1, 1999
This article contains a series of news briefs and updates with regard to Japan's medical device and pharmaceutical markets. Topics include: hospital roles in billing, reimbursing, and controlling medical equipment; pharmaceutical deregulation; liberalized procurement policy for medical products; and drug pricing policy.
January 1, 1999
The Japanese medical market is on the rebound and is expected to grow to 6% annually over the next several years. With 20% of the population over the age of 65 and a growing number of diseases like cancer and heart disease being diagnosed, advanced medical technology from the West is in great demand. This article covers deregulation issues, revision of the National Health Insurance (NHI) system, Japan’s home care market, nursing care for the elderly, pricing and reimbursement, and market entry strategies. As Japan’s government makes changes to its medical market regulations, foreign medical device companies will have growing prospects in the market.
November 1, 1998
Japan's $48 billion market for pharmaceuticals is the largest in the world behind the US, with about 19% of the global market. Ninety percent of the market, however, is dominated by domestic production. Imports account for less than 10% of the total market, and have remained at a constant level for the past several years. The majority of foreign pharmaceutical companies in Japan are large U.S. and European drug companies that manufacture and sell their products locally and/or license compounds to Japanese drug manufacturers. The U.S. and Germany each hold approximately 20% of the Japanese import market for pharmaceuticals, followed by Great Britain with about 11.5%, Sweden with 10%, and Switzerland with 8%.
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.
June 1, 1998
Behind the U.S., Japan’s medical market is the largest in the world. Many foreign medical companies, however, are worrying that Japan’s struggling economy will shrink demand for their medical products in the country. Japan has been experiencing slow growth since the early 1990s, and the Asian currency crisis dealt its economy an additional blow. Nevertheless, economic reforms are underway, and Japan’s demographic changes are driving demand for better-quality medical products. Foreign medical companies are profiting from the Japanese government’s decision to deregulate its medical industry, and can expect the growth of Japan’s medical market to accelerate in the future.
April 1, 1998
Although the mergers and acquisitions (M&A) plan announced by Glaxo Wellcome and Smithkline Beecham at the end of January 1998 ultimately failed, it demonstrated a strong worldwide tendency towards M&A in the pharmaceutical industry. The combined sales of these two companies, as separate entities, presently amounts to $28 billion - a 9% share of the global prescribed medicine market1. If the plan had succeeded, the world's largest pharmaceutical company would have emerged. Over the last 4 years, other large pharmaceutical M&A transactions included:- Ciba Geigy and Sandoz in 1996; Glaxo and Wellcome, and Upjohn and Pharmacia in 1995; Roche and Syntex, and American Home Products and American Cynamid in 1994; and Pharmacia and Carlo Erba, Hoechest and Marion Merrel Dow, Hoechst Roussel and Rhone-Poulenc, and Rorer and Fisons in 1993.
March 1, 1998
In the U.S., the culture and the civil negligence liability system dictates that doctors and hospitals disclose to prospective patients what the illness and proposed course of treatment are, including the benefits and risks. Generally speaking, patients in the U.S. and their families, want to know what their condition is, even if they have an incurable and/or fatal problem.
In Japan, the opposite is true. As a general rule, doctors and hospitals disclose very little, if anything. Doctors and the health establishment in general believe that informing a patient of a fatal condition is announcing a death sentence. In the Japanese culture, this is thought to be an unthinkable cruelty. This culture extends to other non-fatal conditions as well. In fact, it appears to extend across the board. In addition, the law apparently does not grant patients extensive rights to information. On the rare occasions that it does, it is still not clear that doctors or health and health-related institutions comply.
January 1, 1998
This paper provides an introduction to the basic differences between the U.S. and Japanese patent systems and the problems that arise for U.S. medical products companies operating under the Japanese system.
August 1, 1997
Japan's contact lens market was worth 50.8 billion (about $508 million) in 1995. A total of around 30 contact lens manufacturers operate in Japan, including foreign companies. The top five, including Bausch & Lomb, account for 70% of the market. Eye doctors in Japan generally recommend and prescribe hard contact lenses to their patients. As a result, 60% to 70% of Japanese contact lens users wear hard lenses. However, with recent advances in the oxygen-permeability of soft lenses and the introduction of disposable contact lenses (categorized by Japan's Ministry of Health and Welfare as soft lenses), the use of soft lenses is growing rapidly. Due to this growth, soft lenses are potentially in a position to gain dominant market share in the near future.
June 1, 1997
The Japanese market for medical devices has grown steadily since the mid-1990s, despite the general economic slowdown experienced in other sectors of the Japanese economy. The medical-device market grew by 15.8% in 1992, by 19.2% in 1993, and by 12.4% in 1995 -- larger than all other Asian markets combined. Although local production is expected to level off over the next few years, medical device imports are estimated to grow between 5 and 8% a year as the Japanese market opens up in the next few years.
April 1, 1997
In 1995, the Japanese spent $290 billon, or about 7% of their national income, on healthcare. In return for this investment, Japan boasts the world’s longest life-spans and universal health insurance.
It has recently become easier for foreign medical companies to penetrate Japan’s medical market. When Japan entered the harmonized system in 1988, all tariffs and quotas on medical products were eliminated. Despite this, imported medical products, like all imported products in Japan, are still subject to a 3% value-added consumption tax levied on CIF (cost, insurance and freight) value. While the registration procedures and approval process to import medical products to Japan is still complex, specific changes have recently improved the process.
February 1, 1997
Japan is the world’s single largest medical market outside the United States. Product registration in Japan, however, is often complicated and difficult. The direct registration of medical products in Japan via the In-Country Caretaker (ICC) System can help foreign medical companies understand the issues involved in registering products directly in Japan via the ICC system. Although the ICC laws were enacted in 1983, few foreign companies have taken advantage of this strategy due to a lack of knowledge of the law, the cost of creating an ICC, or a lack of knowledge about the distinct advantages of an ICC.
October 1, 1996
Following a period of rapid expansion, Japan's economy has experienced slow economic growth since the late 1980s. Nevertheless, the Japanese medical and dental supplies import market has shown steady growth over the last several years. In 1995, while the Japanese medical market grew only 3%, U.S. medical exports to Japan grew 23% to a total of almost $5 billion. Based on numbers from the Health Industry Manufacturers Association (Washington, DC), this figure represents almost one-quarter of Japan's $21.1-billion medical market. Such rapid growth should continue well into the next century, offering tremendous opportunities for U.S. medical device manufacturers.
September 1, 1995
On November 1, 1994 Ronald Brown, U.S secretary of commerce, and Takakuzu Kuriyama, Japan’s ambassador to the United States, signed the Medical Technology Arrangement (MTA). The agreement marked an important step opening to U.S. manufacturers Japan’s public sector procurement market for medical devices and services.
January 1, 1995
As the environment for importing medical devices into Japan changes, it is important for U.S. firms selling in Japan to understand the implications of the new rules and regulations for their products. Companies should include in their foreign market strategies regular and careful tracking and analysis of these changes, which will allow them to continually reassess product competitiveness and viability, as well as immediately identify new opportunities in the Japanese medical device market.
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.
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.
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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