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MHLW to approve cutting-edge medical devices earlier

  • August 17, 2016
  • , Yomiuri evening edition , p. 6
  • Translation

The Ministry of Health, Labor and Welfare will establish a system that will promptly approve auxiliary artificial hearts, power-assist robotic suits, and other innovative medical devices that are expected to be highly effective. The system will allow these products to be certified based on data obtained from clinical studies to be conducted on a smaller number of patients than the conventional method. The aim is to make new treatments available to patients who need them as quickly as possible and develop the medical equipment industry. The MHLW will introduce the new system by revising a ministerial ordinance within the year.


The early certification system will become available for medical devices that use cutting-edge technology and are highly effective. These products will be tested on a smaller number of samples and the MHLW will approve them if they are confirmed safe and effective using research data from Japan and usage records from other countries. Meanwhile, safety testing to be conducted by manufacturers after the sale of products will involve more patients.


The medical device industry is mainly comprised of smaller manufacturers. The MHLW expects the new system to help these companies secure profits earlier and make it easier for them to conduct research and development. (Abridged)

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