Compilation of a Japanese Device Master File - Seihin Hyojun Sho
The creation of a Device Master File, called a "Seihin Hyojun Sho," is an essential step in obtaining approval to sell a medical device in Japan. The Seihin Hyojun Sho is very similar to a European Technical File, but contains additional information that addresses the specific labeling, packaging and MAH requirements imposed by Japan's Pharmaceutical Affairs Law (JPAL).
This file is a separate from device registration application file (Ninsho, Todokede, Shonin) created during the regulatory approval process. The PMDA is very particular about the content of the Seihin Hyojun Sho and the supporting documents and details submitted for the Seihin Hyojun Sho cannot differ from the same information submitted for the Ninsho, Todokede or Shonin. Even the smallest differences can cause delays.
If you already sell your device in Europe and seek approval in Japan, Emergo Group can help modify your existing Technical File so it can be used for your Device Master File (Seihin Hyojun Sho) in Japan and ensure that all details of documents are aligned with your regulatory submission to Japan's PMDA.Please contact us for more information on how we can create a Device Master File for your medical device.
