【News】 HAL for Medical Use (Lower Limb Type) designated as orphan medical device by MHLW in Japan ~ becomes subject to priority review for marketing authorization~

HAL for Medical Use (Lower Limb Type), developed/manufactured/distributed by CYBERDYNE Inc., has been designated  as an orphan medical device by Ministry of Health, Labour and Welfare (“MHLW”) , Japan. 

With this designation, the HAL will be subject to priority review for marketing authorization to ensure that they are supplied to clinical settings at the earliest possible opportunity, thus further speeding up the medical device(*) approval process for the subject device.

(*) orphan medical device:
In Japan, drugs and medical devices can be designated as orphan drugs or medical devices based on the Article 77-2 of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics if they are intended for use in less than 50 000 patients in the country and for which there is a high medical need.
They are designated by the Minister of Health, Labour and Welfare based on the opinion of the Pharmaceutical Affairs and Food Sanitation Council.
The HAL for medical use (Lower Limb Type) is intended to be used by neuromuscular orphan disease patients and aims to restrain the progress of atrophy and deterioration of the muscles through repetitive and therapeutic use of the device. 

 (REFERENCE) Overview of orphan medical device designation system
http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html