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

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.

SourceCentral Drugs Standard Control Organization

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