成果報告書詳細
管理番号20160000000459
タイトル*平成27年度中間年報 環境・医療分野の国際研究開発・実証プロジェクト 先進的医療機器システムの国際研究開発及び実証 現地国事情に適した高品位透析治療を達成する透析水清浄化システムの研究開発・実証(2)
公開日2016/7/15
報告書年度2015 - 2015
委託先名東レ・メディカル株式会社
プロジェクト番号P11011
部署名ロボット・AI部
和文要約
英文要約Title: International Research and Development and Demonstration Project of Environmental and Medical Field/ International Research and Development and Demonstration of Advanced Medical System/ Research and Development of Water Purification System for dialysate to Achieve High Quality Dialysis Treatment according to the affairs of each area (FY2012-FY2016)/ FY2015 Annual Report

Contents and Achievement of Research Development:
1) We found out that the only medical devices with product registration can be exported to China even if the machine is intended to be used for actual verification in non-clinical situation. Therefore, we concluded agreements for product registration application and its necessary type test with certifying body, Guangdong Medical Devices Quality Surveillance and Test Center, necessary certificates for passing the custom became to be issued from the center after conducting the feasible tests in Japan and confirming the compliance with Chinese regulation.
2) Reverse Osmosis equipment (RO equipment) as well as central dialysis fluid delivery system (central) and dialysis monitor equipment (monitor) are considered as medical equipment in China so that type test is required. Therefore, instead of using TMC RO equipment, we decided to buy and employ TMQ RO equipment which is registered as the manufacturer, Toray Medical (Qingdao) Co., Ltd. (TMQ), who manufactures and sells dialysis machines in China since TMC developed this RO equipment.
3) Generally RO equipment and its upstream preprocessing equipment are individually installed in China, but interlocking control of RO equipment and preprocessing equipment are required for “Central Dialysate Delivery System; CDDS”, which is the dialysis system in this project so we developed this interlocking system.
4) We conducted the electric test and EMC test for the central and the monitor in Japan and confirmed the conformity to Chinese regulation. The required certification for passing the custom was issued by sending this test data to Guangdong Medical Devices Quality Surveillance and Test Center. We are currently continuing to conduct the electric unit test for the important part in the center and will submit the necessary report for the product registration application ultimately.
5) We started preparing to submit clinical trial data in advance to be exempt clinical trial for product registration application.
6) We replaced a series of electric parts which was electrically loaded in domestic electric test and tried to restore to original state as a machine. Furthermore, we also conducted the operation check test.
7) TMC, TMQ and The Second Affiliated Hospital of Nanjing Medical University to which we ship the demonstration equipment discussed and decided the assigned work regarding passing customs in China and transportation within China. We shipped via Nanjing port for Nanjing Medical University assigned part on the other hand via Qingdao port for TMQ assigned part. Both are expected to be delivered to Nanjing Medical University in this fiscal year.
8) We will install the demonstration equipment in The Second Affiliated Hospital of Nanjing Medical University from early next fiscal year and start demonstration evaluation including conformity in the local site.
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