Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices
English translation of Japanese ministerial ordinance establishing GLP standards for nonclinical safety studies of medical devices. This ordinance provides regulatory requirements for laboratory practices in medical device safety evaluation.
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 ↗