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Services: Medical Devices & Supplies

Pharma Training consultants work with clients to obtain approval for the development of medical devices and supplies in Japan. We assist clients with all phases of the approval process:
    Breast Imaging Device
    Pharma Training has consulted with clients to bring innovative products to Japan, including a new automated breast imaging system. Click here to view of demonstration of this device.
  1. If the medical device was approved by the FDA and/or EMEA (or other authority) prior to MHLW, or is currently undergoing trials outside of Japan, we will read and review an investigational plan, preclinical study reports, marketing analysis documents, and regulatory documents so that we can understand the device profile (description, clinical performance, safety, sterilization, stability & durability, and risk analysis) within a confidential agreement with the client.

  2. Pharma Training will create an investigator's brochure in Japanese as a scientific document of the medical device (an investigational plan may be available if needed). This document, outlining the medical device profile and development strategy, is of critical importance to the Japanese Authority. We will therefore conduct a quality check on the consistency between the study data and investigator's brochure (or investigational plan) for the submission documents to the Japanese Authority and Investigators.

  3. A client who intends to get the approval of their medical device from the Japanese Authority will have a PMDA meeting regarding the acceptability of the preclinical and clinical trial data obtained outside of Japan. If a client has to add a clinical trial with Japanese patients along with the international clinical study results, Pharma Training will offer the regulatory strategic plan including Japanese trial protocol as well as the Regulatory Strategy Solution. For a standard medical device, a Japanese trial may not be needed for a submission to the Japanese Authority; for an innovative device or combination device with drug, clients are required to perform a Japanese trial with a small sample size.

  4. Pharma Training will support the preparation of clinical trials in Japan, including clinical trial notification (CTN), Institute IRB submission (with Q&A), operational procedure documents, and GCP audit with the audit timing to be conducted according to SOP and GCP.

  5. Pharma Training will support clients in handling serious adverse event information of the medical device during trials in Japan in compliance with Pharmaceutical Affairs Law as well as ICH-GCP of the pharmaceutical product.

  6. Pharma Training will support clients in preparing the submission regulatory documents. Following submission, Pharma Training will support the quality review (or inspection) by the Japanese Authority so that a client can ensure the quality assurance covering clinical data (under GCP) and preclinical data (under GLP).