The creation of a Device Master File, called a "Seihinhyojunsho," is an essential step in obtaining approval to sell a medical device in Japan. The Seihinhyojunsho is very similar to a European Technical File, but contains additional information that addresses the specific labeling, packaging and Marketing Authorization Holder (MAH) requirements imposed by Japan's Pharmaceutical and Medical Device Act (PMD Act).
This file is separate from the device registration application file (Ninsho, Todokede, Shonin) created during the regulatory approval process. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is very particular about the content of the Seihinhyojunsho and the supporting documents and details submitted for the Seihinhyojunsho 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 can help modify your existing Technical File so it can be used for your Device Master File (Seihinhyojunsho) 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.