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Medical devices and diagnostics cater an integral component of the health care system with a mandate of 'access and equity'. Medical device is an instrument which is applied for diagnosis, therapy, or alleviation of diseases in human beings or animals. Indian medical device sector is emerging with innovative and indigenous solutions. However, the sector seeks support from key stakeholder to contribute to public health. This paper reviews the need of diagnostic capacity building with robust regulatory regime to mitigate the challenges of accessibility in resource poor settings, import dependency, limited innovations with technological & funding constraints and skill set of experts. Further, emphasizes upon promising initiative of government like Make-in-India, which opens new avenues to a flourishing future of indigenous medical health technologies and innovations for delivering affordable healthcare to India's billion-plus population.

Keywords

Medical Devices Rules, 2017, Indian Patents Act, 1970, Central Drug Standard Control Organization, Who, Medical Device, Innovation, Regulatory Capacity Building.
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