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.

Source: Central Drugs Standard Control Organization