The Central Drugs Standard Control Organisation (CDSCO) on October 08, 2024, issued the Medical Device Event Reporting Form.
The following has been stated namely: -
• This form is intended to collect information on Medical Devices Adverse Event in India. The form is designed to be used by Manufacturer/Importer/ Distributor of Medical Devices and Healthcare Professionals with direct/indirect knowledge of Medical Devices Adverse Event.
• Submission of a report does not constitute an admission that medical personnel or manufacturer or the product caused or contributed to the adverse event. Submission of a Medical Devices Adverse Event (MDAE) Report does not have any legal implication on the reporter.
• The Instructions for filling the MDAE reporting form has been stated in the notification.
