K Kumud Pravina
Accepted Abstracts: Pharmaceut Reg Affairs
Medical devices in addition to medicines and other health technologies are essential for patient care, are currently one of the fastest growing industries.They contribute a lot to the global market with the advancement of innovation and technology. WHO is reinforcing its role in providing technical support to its member states to protect their populations from risks of unsafe technology.So,regulatory contrrol is needed over medical devices to prevent the use and importation of substandard devices. Global Harmonisation Task Force's (GHTF) mission is to harmonize the implementation of medical device regulation across the globe,to encourage convergence in standards and regulatory practices facilitating international trade.Different national and international standards were formulated and set for each country to see that materials,process,products are fit for their purpose. Safety and performance of the medical device is monitored for regulation in different phases in the life cycle of a medical device from development to the disposal of the device.Stages in regulatory control involve pre- market,placing on market and post market approval/vigilance to ensure that device meets all its specifications.This is because every device carrries a certain degree of risk and potential problems can never be detected until extensive market experience is gained.They are classified into caegories based on the potential risk they pose.The role of regulatory authority is to ensure that manufacturer has fulfilled all the regulatory requirements.
Currently pursuing my post graduation (M.Pharm)at Andhra University in the branch of Pharmaceutical Analysis and Quality Assurance.Did my graduation(B.Pharm) from Shri Vishnu College of Pharmacy,Bhimavaram.
Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
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