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Communication Key In Receiving PMDA Approval, Accreditation

Devicemakers seeking marketing approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) should facilitate communication with the agency’s inspectors through a close understanding of Japanese quality management system (QMS) rules, preparatory translation of key documents and a skilled interpreter.

A QMS compliance inspection conducted by the PMDA is the most important step in gaining product registration in Japan, David Dills, a regulatory and compliance consultant, said during a recent FDAnews webinar.

The PMDA was established and came into service on April 1, 2004, under the Law for the Pharmaceuticals and Medical Devices Agency, as a consolidation of the services of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME).