Medical Device Adverse Event Reporting Form (India) – For Importers and Manufacturers

Medical Device Adverse Event Reporting Form (India) – For Importers and Manufacturers

This form is designed to capture information on adverse events related to medical devices in India. It is intended to be used by manufacturers, importers, distributors, and healthcare professionals to report incidents and potential device-related issues. The collected data will be used to monitor device safety and identify potential risks.

The Medical Device Adverse Event Reporting Form is a crucial tool for monitoring the safety of medical devices in India. It is mandated by the Medical Device Rules, 2017, under the Drugs and Cosmetics Act, 1940. This form is used to report adverse events, product problems, and near-miss incidents associated with Medical Devices. Key information captured by the form includes:

• Device Details: Manufacturer, importer, distributor, device type, model number, lot number, and expiration date.
• Event Details: Date of event, type of event (adverse event or product problem), location, and a detailed description of the incident.
• Patient Information: Demographic data, medical history, and outcome.
• Healthcare Facility Information: Details of the healthcare facility where the event occurred.
• Investigative Actions: Information on any investigations conducted, root cause analysis, and corrective actions taken.

By submitting this form, healthcare professionals, manufacturers, importers, and distributors contribute to the overall safety and effectiveness of medical devices in India