MHLW Responds to Issue

To cope with the strong demand, the Ministry of Health, Labor & Welfare (MHLW) has organized its Study Panel for Quick Introduction of Highly Demanded Medical Technology. To date, the panel has received 114 requests from 38 medical academies. Of these requests, the specialized working sub-committee selected 94 candidates (59 of which are medical technologies) recommended by 33 medical academies for approval consideration due to the seriousness of the associated diseases and clinical usefulness of the device. The panel finally picked 13 devices as priority devices that should be quickly evaluated and introduced to the market.

The devices selected as a priority for quick introduction include the following:

•    Thoracic aortic stent graft

•    Carotid artery stent

•    Artificial blood vessel

•    Implantable artificial heart

•    Intravascular embolic material

•    Thoracoplasty system

•    Capsule endoscope

•    In-vitro diagnostics

•    Radiotherapy system

•    Implantable Holter ECG monitor

•    Bone cement

•    Radiotherapy supplement system

•    Pacemaker lead dislodgment system

With this decision, the MHLW has asked the manufacturers of these products to release detailed technical information about the device as well as clinical data, usage information in other countries and other relevant information.

Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at [email protected].