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AdvaMed Promotes Medical Device Regulation in India

AdvaMed Promotes Medical Device Regulation in India

The medical devices sector in India needs to be regulated in harmonization with international practices and should to be treated as separate from ‘drugs’, trade association AdvaMed declared. Washington DC-based AdvaMed represents 80 percent of medical technology firms in the US and its member companies produce more than 40 percent of medical devices globally.

AdvaMed Vice President Abby Pratt said that given the significant differences between pharmaceuticals and medical devices, applying the same regulatory and pricing systems for medical devices could reduce the ability of Indian manufacturers to grow.

“In India the disease burden is transitioning from communicable diseases to non-communicable diseases like cancer, diabetes and heart disease and it increases the role of medical technology,” she said. Highlighting the significance of the medical devices sector and its tremendous growth potential Pratt said: “It is valued at USD 4 billion (in India) at present but it is a very important part of healthcare.” She added that the ecosystem for growth would have to be developed so that the sector could realize its tremendous potential to solve India’s healthcare problems.

“There should be a separate regulatory agency for the medical devices with adequate trained personnel. Indian medical devices regulation should be harmonised with the guidelines of  the Global Harmonisation Task Force (GHTF),” according to Ms Pratt.

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