• 2022-05-26 13:46:04

Japan's Adverse Event Glossary are amended to match with the IMDRF's terminologies.

• 2021-12-27 05:35:39

The Japan Federation of Medical Devices Association (JFMDA) has arranged the Japanese “Adverse Event Glossary” and created a mapping chart to match with IMDRF's Adverse Event terminologies.

• 2021-05-22 05:31:34

The Indonesian Ministry of Health has issued guidance on reporting of Adverse Events (in Indonesia: Kejadian Tidak Diinginkan/ KTD). The guidance book explains the types of adverse events (KTD) that must be reported to the Ministry of Health and the reporting period.

• 2021-02-22 02:20:12

This newest announcement is regarding the Device Defect or Adverse Event (AE) Report and Field Safety Corrective Action (FSCAs) Report. It targets to increase level of post-marketing surveillance by including the reporting of device defect or adverse event which occurred in foreign countries.

• 2020-12-23 01:53:56

To further develop a more practical and effective safety surveillance system, TFDA has set up regulations of serious adverse event reporting especially for medical devices. This article leads you into the main differences of the current and upcoming regulations.