Quality Management
Provide concrete recommendations for necessary improvements and support compliance with JGMP.
The PMDA inspects manufacturers and registered manufacturing sites of medical devices or in vitro diagnostic drugs to ensure compliance with the Quality Management System (QMS) standards for manufacturing and quality control of medical devices and in vitro diagnostic devices, verifying that products of appropriate quality are being produced.
The manufacturer or marketing authorization holder submits an application to the investigating authority (PMDA or a registered certification body). At the time of submission, required documents such as QMS-related materials and an overview of the manufacturing process must be provided in addition to the application form.
After reviewing the submitted application, the investigating authority determines the method of inspection and notifies the manufacturer or marketing authorization holder of the inspection procedure, while also requesting any additional documentation if necessary. Inspection methods include document review and on-site inspection.
If deficiencies or points requiring improvement are found during the inspection, they are issued as observations.
Corrective actions are taken in response to the observations, and the details are submitted to the authorities as a corrective action report or plan.
If all criteria are met, a Certificate of Compliance is issued, demonstrating that the QMS of the respective manufacturer or marketing authorization holder complies with legal requirements.
However, minor deficiencies may still be noted, necessitating ongoing improvements.
