CDSCO releases Form for reporting Medical Devices Adverse Event ; designed to be used voluntarily by Manufacturer / Importer / Distributor of Medical Devices, Healthcare Professionals having knowledge of such adverse events
The Central Drugs Standard Control Organization has, recently released a Form for reporting Medical Devices Adverse Event (“MDAE”) designed to be used voluntarily by Manufacturer / Importer / Distributor of Medical Devices, Healthcare Professionals and anyone with direct/indirect knowledge of MDAE.
Information to be provided in the MDAE Form:
- Reporter Details
- Device Category
- Device Details
- Event Description
- Patient Information, History & Outcome
- Healthcare Facility Information (if available)
- Causality Assessment
- Manufacturer/Authorized Representative Investigation & Action taken
After filling up the MDAE form, it can be sent to Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India, Sector-23, Rajnagar, Ghaziabad-20002.