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

Share this:

Sign up for our

Newsletter

You have successfully subscribed to the newsletter

There was an error while trying to send your request. Please try again.

Lexplosion will use the information you provide on this form to be in touch with you and to provide updates and marketing.