Japan's medical Scene

Japanese medical environment and institutions

Compared with other countries, Japan has a population that is aging rapidly, with fewer childbirths and medical costs that have been rising over the years.
Japan's medical settings are characterized by large numbers of hospitals and beds per population, long average hospital stays, high frequency of hospital visits, and a small number of clinicians per patient population.
The Japanese government is working to improve the financial management and operations of medical institutions and enhance the safety of their practices.

Differentiated medical functions

Japanese medical institutions are categorized by their functions into three classes: acute care, recovery and rehabilitation care, and nursing care.
Acute care hospitals, which care for patients who need advanced medical services, are granted intensive funding from the Japanese government, and such hospitals are making their services more efficient, more specialized, and more sophisticated.

Inefficient hospital management in Japan

Due to their high-cost structure, public medical institutions had been suffering from increasing cumulative deficits making it difficult to survive without borrowing money. In 2007, the government took steps to help them rebuild their operations by setting operational benchmarks and numerical targets. The hospitals' efforts to reduce the burden on their operations have yielded some positive results, such as fewer days of average hospital stay, but also led to a decrease in the rate of patients using hospitals. Furthermore, the risk of medical errors in clinical care is unavoidable.
For sustainable operation of medical institutions, it is necessary to make investments to encourage patients to come more often and develop a structure to provide medical services that are safe and secure.

To secure required safety levels

In April of 2005, the law that had defined the safety management responsibilities of medical device manufacturers and marketers was revised and tightened, making these parties assume the same level of responsibility after shipping products as they did before shipping them.

Furthermore, the Medical Service Act and related laws concerning medical practice have changed to require even tighter maintenance management of medical devices.

  • Prepare guidelines for safety management in medical practice
  • Organize a committee for safety management in medical practice
  • Provide employees with training programs for safety management in medical practice
  • Take measures to ensure and promote safety in medical practice, such as self-reporting

Medical safety measures and education

In 2002, the Medical Safety Measures Review Committee of Japan issued its General Measures to Promote Medical Safety with the aim of promoting safety and reliability when providing medical care to patients.
Among these measures is the provision of training programs to ensure patient safety by enabling medical practitioners to acquire the knowledge and skills required to safely provide medical care to patients. Medical education is essential for medical practitioners to achieve the required quality and skill, and proper education requires reviewing and improving the effectiveness of the training.

Government agencies in cooperation with medical institutions is striving together and analyze information on accidents occurring in medical institutions to prevent reoccurrence.

More and more medical institutions are getting involved in this accident information gathering year after year and working more intently on medical safety.

Issues in the Japanese safety standards for medical devices from the viewpoint of overseas manufacturers

Premarket regulations
To start selling your products in the Japanese market, you need to apply for permission to government agencies and the Ministry of Health, Welfare and Labour. Compared with other countries, Japan is known to have a unique authorization process that requires much time and effort in order to bring products to market. This inconvenience, called a "device gap", is the main reason why the latest medical devices from abroad cannot become promptly available to medical institutions in Japan. Overseas manufacturers are also subject to certain regulations.
Postmarket regulations
In Japan, postmarket problems with medical devices are reported by medical institutions, medical device manufacturers, and medical device marketers to the Ministry of Health, Welfare and Labour, and the reporting parties have to address the problems. Not only medical institutions but also medical device manufacturers bear postmarket responsibility and cannot operate their business in Japan without fulfilling these requirements.

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