Emergo can help you implement a vigilance system for adverse event reporting, recalls and post-market monitoring as required by the MFDS.

Regulation on Management of Safety Information Including Medical Device Side Effects, Etc ... Republic of Korea [28159]; Tel : +82-43-719-1564 (for English) | ...

Reportable Adverse Events. In an occurrence or likelihood of death or a serious side effect, information must be reported to the MFDS by the manufacturer or ...

Immediate medical device adverse event (MDAE) reporting indications of Korea include death, life-threatening, hospitalization (initial or prolonged), disability ...

Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center.

Where adverse events occur while using a medical device, a person who obtains approval of a clinical trial protocol shall report them to the Minister of ...

4 окт. 2024 г. · Objective: Immediate medical device adverse event (MDAE) reporting indications of Korea include death, life-threatening, ...

In case you have experienced any adverse event related to the use of Linde Healthcare products and/or services, please fill out the form below with as much ...

This guidance shall apply to the approval/certification of the manufacturing/import, review of technical documents, and approval of clinical trial protocols.

1 нояб. 2017 г. · When reporting adverse events, the amount of safety information collected will be more detailed than before. A revision of a “serious adverse ...