Post Market Surveillance is required for manufacturing/Marketing Authorization Holders (MAH) selling medical devices or pharmaceuticals in Japan. Failure to comply with reporting requirements could lead to a product recall and/or loss of market access. Post Market Surveillance in Japan consists of recording and reporting adverse events (known as Fuguai) in addition to taking corrective actions if needed.
Post market surveillance is overseen by both the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). The organizations work in tandem to collect adverse event data and promote the safe usage of medical and pharmaceutical devices by listing package inserts, product recalls, drug guides for patients and other urgent safety alerts as well as reports on adverse drug reactions and adverse events of medical devices submitted to the PMDA.
Adverse Events Reporting Timeline
The MAH must report serious Adverse Drug Reactions (ADR) to the MHLW within 15 days (new drugs on the market for less than 2 years must report within 30 days). Non serious ADRs must be reported on an annual basis. Adverse Events are reported using an online system, Electronic Transmission of Individual Case Safety Reports.
Adverse Events occurring in other countries with devices that are approved in Japan are reportable to the MHLW.
Contact Asia Actual with questions regarding Post Market Surveillance in Japan. Our local, bi-lingual regulatory experts are well positioned to assist.