• 2026-10-26 09:33:44

The Ministry of Food and Drug Safety (MFDS) of South Korea has recently revised regulations concerning medical device adverse event reporting and Korean Good Manufacturing Practice (KGMP) and introduced a new regulation governing the designation and management of organizations involved in medical device quality management.
These regulatory updates aim to clarify adverse event reporting requirements and timelines, while improving regulatory clarity by separating KGMP conformity assessment requirements from provisions governing assessment bodies and training organizations.
This newsletter provides an overview of three regulatory updates that took effect on July 1 and September 22, 2026.

• 2026-06-26 06:31:01

The FDA's Electronic Medical Device Reporting (eMDR) program requires medical device manufacturers and importers to submit Medical Device Reports (MDRs) electronically for adverse events, malfunctions, and other reportable incidents. The eMDR system improves the efficiency, accuracy, and timeliness of post-market surveillance by enabling electronic submission, processing, and tracking of reports through FDA systems. Manufacturers should establish robust procedures to ensure compliance with eMDR requirements and maintain effective post-market monitoring of device safety and performance.

• 2024-06-19 09:02:05

This guidance outlines safety reporting procedures, including prompt reporting of serious adverse events (SAEs) and device deficiencies with causal relationships, for in vitro diagnostic medical devices (IVDs) in performance studies.

• 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.

• 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.