The Ministry of Health and Family Welfare (MoHFW) on December 06, 2025, issued the Draft Medical Devices (......Amendment) Rules, 2024, to further amend the Medical Device Rules, 2017.
The following has been stated namely: -
• The Chapter IX has been substituted to state “Duties of Medical Device Officer, Medical Device Testing Officer”
• Rule 85 which states “” the following has been inserted namely: -
“(xi) The person holding registration certificate shall furnish reports of the results of tests or evaluation of a medical device in Form MD-44”
• Form MD-44 which states “Report of Test or Evaluation by registered Medical Device Testing Laboratory” has been inserted in the Draft.
Objections and Suggestions may be sent within 30 days to Secretary (Drugs), Ministry of Health and Family Welfare, Government of India or emailed at [email protected].
[Notification No. G.S.R. 883(E)]
