Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies having a large footprint in manufacturing and training in India, today said the formulation of DTAB sub-committee to examine proposal for inclusion of compensation in the policy framework on medical devices is a step in the right direction.
Drugs Technical Advisory Board (DTAB), a panel under the Union Health Ministry, has decided to set up a sub-committee to assess the issues related to proposal for amendment of MDR 2017 to include provisions for compensation in case of injury or death due to malfunctioning of medical devices or if the devices are found unsafe or non-compliant with the conditions of licence.
The committee is headed by Principal Consultant in Directorate General of Health Services (DGHS), Dr. B.D. Athani and has representatives of the government, AIIMS and Safdarjung Hospitals, Medical devices industry, and consumers.
“The inclusion of Medical Device industry in the subcommittee is a positive step towards having a well-rounded decision on the proposal for inclusion of compensation in the Medical Device Rules. We will work with the expert panel to form a suitable framework on compensation, keeping in mind the interest of the stakeholders,” MTaI Chairman and Director General Mr. Pavan Choudary said.