Japanese government to ease regulations for medical devices

Kugako Sugimoto, NOST Tokyo

Originally published on the site of NL Agency

Summary

The Japanese government declared easing of regulations for medical equipment in the plan, ‘Rebirth of Japan: Comprehensive Strategy’, to leverage the medical device companies in Japan. In fiscal 2011, Japan imported medical devices more than it exported. Especially Japan wants to invent revolutionary therapeutic devices that are currently weak exports in the global market. Now major medical device companies watch opportunities for R&D, production, and sales outside Japan.

Details

The new economic plan, Rebirth of Japan: Comprehensive Strategy, was endorsed by National Policy Unit, Cabinet Secretariat, Japan in 2012 and it included regulatory reform considering the characteristics of medical equipment and regenerative medicine. To obtain international marketing competence, the Japanese government declared easing of regulations for medical equipment. However, the budget and the exact measures for this plan to work still need time to be provided. In fiscal 2011, Japan imported medical devices (nine billion euro) more than it exported (four billion euro). Though it also produces own medical devices for domestic use, it heavily depends on imported devices. Especially, international competence of its therapeutic device was weaker compared to its diagnostic devices. Most pacemakers, Implantable Cardioverter Defibrillators (ICD), catheters, and stents are imported. While waiting for the start of the rebirth plan, Business Monitor International Ltd reported on medical devices companies in Japan on January 1, 2013. The report includes major players such as Aloka, Canon, Fukuda Denshi, Hitachi, Hogy Medical, Hoya, Konica, Nidek, Nihon Kohden, Nipro, Olympus Optical, Omron, and Shimadzu. To survive in the international business, these companies aim at overseas partnership to make breakthrough in the production and R&D of revolutionary medical devices.

Olympus Optical

The company produces endoscopic products and claims to hold eighty percent of the world market for endoscopes. Business lines are endoscopies, endosurgery, and endotherapy products. The company aims to early detection of diseases and minimally invasive ways to treat disease. The company has manufacturing sites in Germany, the UK and Vietnam besides in Japan. Now Olympus Optical puts efforts into the production in Vietnam to cut costs.

Nihon Kohden

Nihon Kohden is a manufacturer, developer and distributor of medical electronic equipment. The company’s principal products are patient monitors, defibrillators, electromyograph systems, electrocardiographs, electroencephalographs (EEG), and hematology analyzers. The company is trying to enhance its overseas position by establishing new sales subsidiaries in US, Europe, Latin America, South Asia, South-East Asia, and Middle East. Holst Center, set up by TNO (The Netherlands) and IMEC (Flanders, Belgium), is currently cooperating in the R&D of EEG with Nihon Kohden.

Canon

Canon sees medical technology is important for next generation expansion of their business and will put effort in this field. It produces ophthalmic equipment, digital radiography systems, AED, and sphygmomanometer and provided their technology to the medical devices of Philips and SuperSonic Imagine Ltd. The company is targeting medical revenue of 100 billion yen by 2015. The company has manufacturing and research divisions throughout the world. In February 2012, Canon acquired Delft Diagnostic Imaging, a Dutch manufacturer, specializing in innovative medical Picture Archiving and Communication System (PACS) software solutions, digital X-ray imaging systems, and system integration.

Terumo

Termo was founded in 1921. It manufactures and sells medical products and equipment including blood glucose monitoring system, cardiovascular systems, peritoneal dialysis. Global network extends Europe, Middle East, Africa, Asia, and North & South America. The company produces items such as syringes, catheters, introducers for interventional radiology and tubing packs for open heart surgery in Europe though most products are produced in Japan and in the US. It sees Europe is a good place for clinical study and pre-sale according to their global business strategy.

Nipro

Nipro operates three main business segments; medical, pharmaceutical and materials (mainly medical glass products). The company is planning to build more overseas factories in countries such as in the US, China, and India in order to raise production from thirty percent to more than sixty percent of overall output by fiscal 2015.

Hitachi

Hitachi Medical Corporation was founded in 1949. The company produces MRI system, CT system, diagnostic ultrasound system, optical topography system, and X-ray related system. The company now focuses Europe and Japan for the sale of MRI systems that was used to be intensively sold in North America.

Omron

Healthcare business of Omron is one of their diversified business fields. Omron Healthcare provides blood pressure monitors, digital thermometers, body composition monitors, pedometers, nebulizers for personal use and blood pressure monitors, non-invasive vascular monitors, portable electrocardiograms (ECGs), and patient monitors for professional use. Omron Healthcare Europe deals in blood pressure monitoring, respiratory therapy, activity monitoring, weight management, electronic nerve stimulation for personal use, and electrocardiograph for professional use.

Fukuda Denshi

Fukuda Denshi manufactures and sells medial electronic equipment including equipment for physical examination, patient monitoring and other diagnostic and therapeutic tasks, home healthcare, physical therapy, preventive healthcare and emergency medical services. Fukuda Denshi sells their products in the worldwide scale and claims to be Japan’s leading manufacturer of ECGs with an approximate fifty market share. Fukuda Denshi also imports and sells medical equipment from overseas to the Japanese market.

 

Source

The Japan Federation of Medical Devices Associations (JFMDA)

Japan Medical Devices report by Business Monitor International Ltd. 2013/01/14

Olympus Optical

Nihon Kohden

Canon

Terumo

Nipro

Hitachi Medical Corporation

Omron

Fukuda Denshi

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