Post Marketing Surveillance: (i) Subsequent to approval of an Investigational medical device, it shall be closely monitored for their clinical safety once they are marketed. The applicants shall furnish Periodic Safety Update Reports (PSURs) in order to, — (a) report all the relevant new information from appropriate sources; (b) relate these data to patient exposure; (c) summarise the market authorisation status in different countries and any significant variations related to safety; and (d) indicate whether changes will be made to product information in order to optimize the use of the product. (ii) One medical device should be covered in one PSUR. Within the single PSUR separate presentation of data for different indications or separate population need to be given. (iii) All relevant clinical and non-clinical safety data will cover only the period of the report (interval data). The PSURs shall be submitted every six months for the first two years after marketing approval of the medical device. For subsequent two years, the PSURs need to be submitted annually. The Central Licensing Authority may extend the total duration for submission of PSURs if it is considered necessary in the interest of public health. PSURs due for a period must be submitted within thirty calendar days of the last day Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 173 of 248 of the reporting period. However, all cases involving suspected unexpected serious adverse event shall be reported to the licensing authority within fifteen days of initial receipt of information by the applicant. If marketing of the medical device is delayed by the applicant after obtaining approval to market, such data will have to be provided on the deferred basis beginning from the time the medical device is marketed. (iv) New studies specifically planned or conducted to examine a safety issue should be described in the PSURs.