Our Record of Regulatory Approvals　

From 1978 to date, we have obtained more than 900 regulatory approvals and acquired expertise in resolving various issues and challenges arise from the application process.

Medical Devices Approval (SHONIN), Certification (NINSHO), Notification (TODOKEDE)

In total,
more than 900 items (from 1978 to November 2018)
more than 400 items (from 2005 to November 2018), refer to the table below for details
医療機器承認、認証、届出
Class Ⅳ New Approval Application Partial Change Application(PCA) Minor Change Notification(MCN)
9 28 64
Class Ⅲ 8 13 42
Class Ⅱ 26 31 149
Class Ⅰ 41 29 N/A

Clinical Trial

Clinical trial (e.g. coronary artery stent, blood vessel prosthesis, aortic stent graft etc.) 9

Registry

Registry 5

Request for Reimbursement Listing

Category C 7
Category A/B More than 100 items
Total More than 100 items

Our Progress of Regulatory Approvals and Clinical Trials

1995

Conduct of the Japanese clinical trial of a coronary stent; GR (Gianturco-Roubin) Flex Stent
1997

Conduct of the Japanese clinical trial of the Intergard Woven, Intergard Knitted
2006

Conduct of the Japanese clinical trial of a AAA Stent Graft, followed by first ever approval in Japan as a new device

2011

First approval of a thrombectomy device for acute cerebral thrombosis as an aspiration catheter in Japan, using extrapolated foreign clinical trial data.
2013

Conduct of the US-Japan global clinical trial of an intracranial stent (from 2013 to 2016)
2014

Expansion of indications of conventional AAA stent graft treatment, using extrapolated foreign clinical trial data

2016

Conduct of the Japanese clinical trial of a laser fiber for endovenous ablation treatment for lower-limb varicose veins

Conduct of the first pivotal clinical trial of Transcatheter Aortic Valve Implantation (TAVI) in Japan (from 2016, and discontinued in 2017)
2019

Conduct of the US-Japan global clinical trial of a femoral artery stent

Medico's Hirata