Accelerating the regulatory submission process for a medical device in Japan

In Japan, medical devices are regulated by the Pharmaceuticals and Medical Devices Agency (PMDA) under the Pharmaceutical and Medical Device Act. The process typically involves preparing a Summary Technical Documentation (STED) conducting pre-submission consultations with PMDA, submitting the application, responding to inquiries and awaiting approval. The timeline can vary significantly depending on the device classification and the quality of the submission.