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As per the Seventh Schedule of the Medical Devices Rules, 2017, the Periodic Safety Update Report (PSUR) should include the following actions related to safety:
– Safety-related actions: Any new or ongoing safety-related actions, including recalls, field safety corrective actions, and other risk minimization measures.
– Changes to reference safety information: Any changes to the product information or labeling related to safety.
– Signal and risk evaluation: Evaluation of new safety signals and any changes to the known risks associated with the medical device.
– Overall safety evaluation: An overall assessment of the benefit-risk profile of the medical device.