Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan

Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan

Background: Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Methods: To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of c...

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Bibliographic Details
Main Authors: Nobuhiro Handa, Kensuke Ishii, Yutaka Matsui, Yuki Ando
Format: Article
Language:English
Published: Elsevier 2015-09-01
Series:EBioMedicine
Subjects:
Adverse event report
Cardiovascular device
Registry
Pharmaceuticals and Medical Devices Agency
Online Access:http://www.sciencedirect.com/science/article/pii/S2352396415300669

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http://www.sciencedirect.com/science/article/pii/S2352396415300669

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