Publications on Japan

Increased Cooperation Between Japan, EU, Canada, and US

Japan 's Ministry of Health, Labor, and Welfare (MHLW) with the Pharmaceuticals and Medical Devices Agency (PMDA) concluded confidentiality agreements with the European Commission's Directorate General Enterprise and Industry and Health Canada. Both these agreements were signed in October 2009. The United States and Japan issued a report detailing the progress of the US-Japan Regulatory Reform and Competition Policy Initiative. The Initiative was established to encourage fairer competition, improve the business environment in Japan, and promote bilateral economic growth through regulatory reform.

Japan Quality Audits 2010

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.

Japan QMS Audit for Medical Device Registration

Make sure you are prepared for your Japan medical device registration by fully understanding the QMS auditing process. Audits can either consist of a document review or an on-site inspection. This presentation describes how to prepare for your audit and what the process entails. This 90-minute session includes a 60-minute presentation, followed by 30 minutes of Q&A.

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.

Updates on Japan's Expanding Medical Device Market

As the second largest medical market in the world, Japan is constantly striving to improve its regulatory system to meet demand. New consultation sessions, plans to increase staff and reviewers, and goals to enforce shorter review times are just some of the new changes Japan�s Pharmaceuticals and Medical Devices Agency is implementing. Learn more about Japan�s medical device regulatory environment and make sure you are prepared. This webcast will provide an overview of Japan�s medical device market, including information on the most recent regulatory issues. The presenter is Ames Gross, president of Pacific Bridge Medical.

Lost in Translation: The Challenges of a QMS Audit

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.

Doing Business in Japan

With the third largest economy in the world, Japan is an attractive market for Western companies looking to expand internationally. To do successful business in Japan, however, Westerners need to understand Japanese culture and business etiquette. The strongly hierarchical group mentality and distinct social etiquette in Japan require careful consideration in your business proceedings with Japanese people. Learn more about Japanese business culture (e.g., how Japanese companies balance business and social proceedings or common mistakes that Western companies make) in this 90-minute webcast presentation. It includes a 60-minute presentation, followed by 30 minutes of Q&A.

Japan Audit for Medical Device Registration

Make sure you are prepared for your Japan medical device registration by fully understanding the QMS auditing process. Audits can either consist of a document review or an on-site inspection. This webcast CD will describe how to prepare for your audit and what the process entails. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.

Japan Audit and Accreditation for Foreign Medical Device Manufacturers

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.

Medical Device Reimbursement in Japan

The Japanese economy has rebounded over the last few years, after almost 15 years of stagnation. The unemployment rate hit an eight-year low of 4.0 percent in May 2006 and private consumption has risen at an annual rate of 1.2 percent since 2002 . Domestic sales growth has also grown by about 2 to 3 percent. Japan’s medical device market is no exception, being worth over $25 billion -- a considerable portion of the total Asian medical device market of approximately $36 billion. With its rising elderly population, demands for medical devices and healthcare continue to increase in the country.

Japan Audit and Accreditation for Foreign Device Manufacturers Webcast

This webcast provides an overview of Pharmaceuticals and Medical Devices Agency (PMDA) inspections of foreign device manufacturers and foreign device manufacturer accreditation system in Japan. Topics covered include who will be inspected, what items will be reviewed during audit, best ways to prepare for the audit, among others.

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.

New Japanese Medical Device Regulations After April 2005 Through January 2006

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.

New Japanese Medical Device Regulations Webcast

This webcast provides an overview of Japan’s most recent medical device regulations post April 1, 2005. Topics covered in the webcast include the new requirements for master file registration, new requirements for applying for a foreign manufacturer certificate, new requirements for GCP compliance review, new GVP requirements, among others.

The New Marketing Authorization Holder (MAH) System for Medical Devices in Japan

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.

Japan's New Regulatory Environment for Medical Devices (PDF)

This presentation will provide an overview of the changing regulatory environment for medical devices in Japan. Information outlined in the presentation includes the changes in Japan’s medical device registration process following the implementation of the new Pharmaceutical Affairs Law in April 2005, and the new Marketing Authorization Holder system.

How to Do Business in Japan (PDF)

U.S. companies need to carefully consider their regulatory and business strategies in order to be successful in the Japanese medical device market. This presentation outlines strategies on conducting a distributor search, setting up an office in Japan, and also provides an overview of the Japanese medical device market. Information is provided on locating and signing up a distributor, including how to establish a good relationship with a distributor and how to handle distributor problems. Various types of Japanese business structures and their basic requirements are described, such as a representative office, branch office, subsidiary and joint venture. In addition, this presentation outlines Japan’s medical device regulatory environment, including the Ministry of Health, Labor and Welfare (MHLW), Pharmaceutical and Medical Device Agency (PMDA), New Pharmaceutical Affairs Law (PAL), and new Marketing Authorization Holder (MAH).

How to Get the Right Regulatory Assistance in Japan

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.

Recent Revisions in Japan's Pharmaceutical Affairs Law for Medical Devices

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.

Global Perspective: The Regulatory Environment for Medical Devices in Japan

Foreign companies looking to penetrate medical device markets in Asia need to pay close attention to the regulatory environment in order to handle the difficulties that await them. Japan’s medical device market is the second largest market in the world, worth almost US$23 billion. The Japanese government, through the Ministry of Health, Labour, and Welfare (MHLW), is making an effort to liberalize the medical device market and revise its guidelines to improve healthcare for its citizens and keep healthcare expenditure to a minimum. Previously, clinical trials in Japan were conducted under the Good Clinical Practice Standards (GCP) and followed by the Post Marketing Assessment (PMA) reporting. Recently, the U.S. and Japan signed the Market-Oriented, Sector-Selective (MOSS) agreement, which will allow foreign firms to use foreign clinical testing data, saving them a great deal of time and money. Clinical trials are just one of the issues being tackled. This article examines the many steps that the Japanese government is taking to expand its medical device market.

Direct Registration of Medical Products in Japan: A Case Study

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.

Opportunities in Japan’s Medical Device Market

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.

2000 Update on Japan's Medical Device Market

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.

Japan 2000 Pharmaceutical Change: New Good Clinical Practice (GCP) Requirements

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.

Japan Medical Device Market 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.

Japan: 1999 Year-End Medical Device Update

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.

Entering the Japanese Medical Device Market

Japan’s recent economic recession has not slowed the great demand for technologically innovative products that are flooding the Western medical markets. The country’s aging population and the government’s efforts at deregulating the distribution process are some of the main factors pushing Japan’s medical device market to new levels. Subsequently, Western companies have numerous opportunities to take advantage of the Japanese market demands, and may utilize several different methods when penetrating the medical market. Some of these methods include marketing through a distributor, marketing through a joint venture, going through another foreign company, and using direct marketing. Foreign companies may also find success within the market by manufacturing in Japan, as well as setting up representative offices to promote the company. This article highlights some of the main factors that are increasing demand within the Japanese medical market, deregulation efforts, and market entry strategies.

Japan Pharmaceutical Update

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.

Japan Medical Regulatory Update

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.

All Medical Devices in Japan - 1999 Update on Japan's Medical Device Market.

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.

Regulatory Changes in Japan's Pharmaceutical Industry

New Trends in Japan's Medical Device Market (PDF)

Japan's Medical Device Industry: A Growing Market for Foreign Companies

Reorganization of the Japanese Pharmaceutical Industry

Patient Disclosure Rights in Japan's Healthcare System

Japanese Patent Law: An Introduction for Medical Companies

Japan’s Contact Lens Industry: Antitrust Issues and the Role of the JFTC

Direct Product Registration in Japan: The ICC System

Keeping Up with Changes in the Japanese Medical Device Market (PDF)

Entering the Japanese Market: Huge Opportunities, Complex Regulations

Registering Medical Products in Japan

The In Country Caretaker System in Japan (PDF)

Marketing and Distributing Medical Products in Japan

U.S.-Japan Trade Talks Produce Medical Technology Arrangement

Changing Regulatory Environment in Japan's Medical Device Industry Opens New Opportunities for American Companies