A PSUR should be structured as follows:— (a) Title Page: The title page of PSUR shall capture the name of the Medical device; reporting interval; approved indication of Medical devices; date of approval of the medical device; date of marketing of medical device; licence name and address. (b) Introduction: This section of PSUR shall capture the reporting interval; medical device's intended use, mode of action or principle of operation, risk class and a brief description of the approved indication and population. (c) Current worldwide marketing authorization status: This section of PSUR shall capture the brief narrative overview including details of countries where the device is currently approved along with date of first approval, date of marketing and if the product was withdrawn in any of the countries with reasons thereof. (d) Actions taken in reporting interval for safety reasons: This section of PSUR shall include a description of significant actions related to safety that have been taken during the reporting interval, related to either investigational uses or marketing experience by the licence holder, sponsor of a clinical investigation, regulatory authorities, data monitoring committee, or Ethics Committee. (c) Changes to reference safety information: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 174 of 248 This section of PSUR shall capture any significant changes to the reference safety information within the reporting interval. Such changes will include information relating to contraindications, warnings, precautions, adverse events, and important findings from ongoing and completed clinical investigations and significant non-clinical findings. (f) Estimated patient exposure: This section of PSUR shall provide the estimates of the size and nature of the population exposed to the medical device. Brief descriptions of the method used to estimate the subject exposure shall be provided in terms of, — (i) Cumulative and interval subject exposure in Clinical investigation; (ii) Cumulative and interval patient exposure from Marketing Experience in India; (iii) Cumulative and interval patient exposure from Marketing Experience from the rest of the world. (g) Presentation of individual case histories: This section of PSUR shall include the individual case information available to a licence holder and provide brief case narrative, medical history indication treated with suspect medical device, causality assessment and provide following information:— (i) Reference prescribing information (ii) Individual cases received from India (iii) Individual cases received from rest of the world (iv) Cumulative and interval summary tabulations of serious adverse events from clinical investigations (v) Cumulative and interval summary tabulations from postmarketing data sources (h) Studies: This section of PSUR shall capture the brief summary of clinically important emerging efficacy or effectiveness and safety findings obtained from the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 175 of 248 licence holder sponsored clinical investigation and published safety studies that became available during the reporting interval which has the potential impact the product safety information. (i) Summaries of Significant Safety Findings from Clinical investigation during the reporting period (ii) Findings from Non-interventional Studies (iii) Findings from Non-Clinical Studies (iv) Findings from Literature