Other information: This section of PSUR shall include details about signals and Risk Management Plan, if any, put in place by the licence holder. (a) Signal and risk evaluation: In this section the licence holder shall provide details of signal and risk identified during the reporting period and evaluation of signals identified during the same period. (b) Risk Management Plan: In this section the licence holder shall provide brief details of safety concerns and necessary action taken by him to mitigate such safety concerns. (j) Overall Safety Evaluation: This section of PSUR shall capture the overall safety evaluation of medical device based on its risk benefit evaluation for approved indication. (i) Summary of Safety Concerns (ii) Benefit Evaluation (iii) Benefit Risk Analysis Evaluation (k) Conclusion: This section of PSUR shall provide details on the safety profile of medical device and necessary action taken by the licence holder in this regard. (I) Appendix: The appendix includes the copy of marketing authorization in India, copy of prescribing information, line listings with narrative of Individual Case Safety Reports (ICSR). Note : Table means "Table" given below this Schedule.