Medical Device QMS and GMP Inspection Program
PMDA inspection and assessment program for medical device quality management systems (QMS) and good manufacturing practices (GMP). Covers registered certification bodies and MDSAP assessments.
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 ↗