Ministerial Ordinance on Good Clinical Practice for Medical Devices
English translation of Japanese ministerial ordinance establishing GCP standards for clinical studies of medical devices. This ordinance defines requirements for conducting clinical trials and evaluating medical device safety and efficacy.
Manufacturers and sponsors placing medical devices on the Japan market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗