Below you will find basic demographic and healthcare market data on Japan, plus specific information about the medical device and healthcare industries.
Overview of medical device industry: Japan is an economic powerhouse, and its medical device market is one of the biggest in the world. The Japanese medical device industry was valued at US$28.1 billion in 2016 and is projected to grow steadily through 2020, when it should reach over US$31.7 billion.
Japan has a robust domestic manufacturing market. Many major Japanese producers are well-known outside Japan. Yet, the majority of the medical devices used in the Japanese healthcare system are imported from other markets. Despite Japan's reputation as a hub of technological innovation, there is still opportunity for foreign manufacturers in the medical device sector.
Opportunities in the Japanese market: Japan has a very large aging demographic; over 25% of the Japanese population is older than 65. This makes it a very attractive market for foreign manufacturers, especially those marketing devices used in treating lifestyle and age-related conditions. There is strong demand for interventional cardiology equipment, pacemakers, orthopedic implants, home care, preventative care, and innovative technologies.
Industry challenges in Japan: The Japanese regulatory process can be lengthy and expensive. Regulations and documents are published almost exclusively in Japanese and the PMD Act imposes strict requirement and clinical standards for foreign manufacturers. An experienced regulatory partner with a presence in Japan is essential. As such, large corporations with the resources to push through the regulatory process already have a strong hold on the Japanese market.
Foreign manufacturers can also expect hefty competition from domestic manufacturers. Japan is home to leading consumer technology companies that also design medical devices. The greatest competition is in diagnostic imaging, therapeutic and surgical equipment, biophenomena measuring and monitoring systems, home therapeutics, dialyzers, and endoscopes.
| JAPAN | CHINA | UNITED STATES | |
|---|---|---|---|
| Population | 126,919,659 | 1,367,485,388 | 321,368,864 |
| Primary language(s) | Japanese | Chinese, Mandarin | English |
| Total healthcare spending | $469 billion | $574 billion | $3 trillion |
| Healthcare expenditures total (% of GDP) | 10.2% | 5.5% | 17.1% |
| Healthcare expenditures per capita | $3703 (USD) | $420 (USD) | $9403 (USD) |
| Expenditures on healthcare | Government: 84% Private: 16% |
Government: 56% Private: 44% |
Government: 48% Private: 52% |
| Size of medical device market (USD) | $26 billion (USD) | $8.7 billion (USD) | $147.7 billion (USD) |
| Number of hospital beds | 13.7 per 1000 people | 3.8 per 1000 people | 2.9 per 1000 people |
| Age distribution | 0-14 years: 13% 15-64 years: 60% 65 years and over: 27% (2015 est.) |
0-14 years: 17% 15-64 years: 73% 65 years and over: 10% (2015 est.) |
0-14 years: 19% 15-64 years: 66% 65 years and over: 15% (2015 est.) |
| Life expectancy at birth | Male: 81 years Female: 88 years |
Male: 73 years Female: 78 years |
Male: 77 years Female: 82 years |
| Currency | Yen | Renminbi yuan (￥) | US dollar ($) |
Want to see how Japan compares to many other countries in Europe and around the world? Download our free PDF Healthcare spending by country.
自2018年起，美国食品和药物管理局（U.S. Food and Drug Administration，FDA）开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年，为推进以电子格式提供510(k)递交文件的过渡，美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多近年来，全球医疗法规监管日新月异，各国、各地区监管机构纷纷出台、变更当地法规。与此同时，作为全球第一大医疗器械市场的美国，在其法规领域也做出诸多变化。这给不少以上市美国市场为目标的医疗器械企业及制造商带来了不小的挑战。 对此，Emergo by UL法规专家团队准备举办一场线上研
阅读更多