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Summary of Current Requirements for Where to Send Adverse Event Reports.



Study Group 2 has made an attempt at producing unified guidance regarding who should adverse event reports must be sent to. The main alternatives discussed were: 1. Submission of reports to every regulatory authority of the countries where the device subject of the adverse event report is marketed; 2. Submission of a single report to the regulatory authority of the country in which the adverse event took place, and 3. Submission of a single report to a central global repository (database) of adverse event information.

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