In Japan, steps in a medical device audit include 1) Submitting necessary documents to the Pharmaceuticals and Medical Devices Agency (PMDA); 2) PMDA review and assessment; 3) In some cases, on-site inspection by the PMDA; 4) Evaluation of GMP manufacturing facilities and quality systems; 5) Examination of device safety and efficacy data; 6) Issuance of an audit report and quality compliance.
