Medical Device Related Adverse Event Committee (MDAEC)

Materiovigilance Program of India (MvPI) | Medical Device Safety Cell

Institutional Notification & Mandate

In reference to the National Medical Commission (NMC) Policy & Coordination Division (Memo No. CDL-20011/139/2025-COORDINATION-NMC dtd. 13.07.2025), Jagannath Gupta Institute of Medical Sciences & Hospital (JIMSH), Budge Budge, Kolkata, has been successfully enrolled with the Materiovigilance Program of India (MvPI), Government of India.

MDAEC Notification

Ref No.: JIMSH/PRI-2025/07-33
Date: 24.07.2025
Statutory constitution of Medical Device related Adverse Event Committee.

Objectives & Scope of Responsibilities

The Medical Device related Adverse Event Committee (MDAEC) functions in coordination with the Indian Pharmacopoeia Commission (IPC), Ghaziabad to oversee clinical device safety across all hospital wings:

  • Monitoring, systematically assessing, and preventing adverse events and complications associated with medical devices, surgical implants, and diagnostic equipment.
  • Enabling timely causality assessments and reporting of medical device malfunctions to the national Materiovigilance database (MvPI).
  • Formulating Standard Operating Procedures (SOPs) under the direction of the Secretary, Chairperson, and Co-Chairperson for institutional device safety governance.
  • Facilitating multidisciplinary coordination between clinical specialists, biomedical engineers, nursing superintendents, and the hospital pharmacy.

Medical Device Related Adverse Event Committee (MDAEC)

Constituted as per National Medical Commission (NMC) requirements under Ref. No. JIMSH/PRI-2025/07-33:

Sl. No. Designation / Department Position
1 Principal Chairperson
2 Medical Superintendent cum Vice Principal Co-Chairperson
3 Head, Department of Pharmacology Secretary
4 Head, Department of Orthopaedics Member
5 Head, Department of General Medicine Member
6 Consultant In-Charge, Intervention Cardiology Member
7 Head, Department of General Surgery Member
8 Head, Department of Obstetrics & Gynaecology Member
9 Head, Department of Ophthalmology Member
10 Nursing Superintendent Member
11 Coordinator, MDMC-MvPI of JIMSH Member
12 In-Charge, Biomedical Engineering Member
13 In-Charge, Hospital Pharmacy Member
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