Japan Introduces Online Application For Medical Devices

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has developed an online system for the submission of registration applications for medical devices in Japan. The online portal, known as DWAP (WEB medical application platform), started accepting electronic applications with effect from April 25, 2011.

Applicants for medical devices are required to obtain an identification code to commence the online application procedure through DWAP. An electronic barcode is also given to applicants for efficient processing and for subsequent reference. All information provided through the online application system must be in Japanese.

Some of the medical device application documents that can be submitted electronically through DWAP include (and are not limited to) the following:

  • Application form for Medical Devices Manufacturing and Marketing
  • Notification for Medical Devices Manufacturing and Marketing
  • Application form for Medical Device Compliance Inspection
  • Notification for medical device manufacturing for export / import
  • Written notifications of Manufacture and Sale of Medical Equipment
  • Application form for medical re-evaluation

For more information on PMDA’s DWAP system, go to https://www.dwap.pmda.go.jp (in Japanese only)