The investigator shall immediately report to the clinical trial institution, sponsor, and IRB serious adverse events and event that could have led to a serious adverse device effect. The immediate reports shall be followed by detailed, written reports.

In addition to those provided in Article 38 of this Act, the sponsor shall report to the central competent authority about device deficiencies that could have led to a serious adverse device effects.
The reporting referred to in the preceding paragraph shall be made within 7 days after becoming aware of the actual happening of the occurrence, and detailed investigation information shall be submitted to the central competent authority within 15 days.

The sponsor specified in Article 12 shall inform all investigators in writing of all the serious adverse events at all medical trial institutions that have been reported to sponsor, and ensure that they are reported to their IRBs.