Regulatory aspects of medical devices in India
Keywords:
Medical devices, classification, regulatory, license, marketingAbstract
Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.
References
. Sanjana P, Kirti H, Sajeli Begum A. Medical devices and their approval procedure in India. International Journal of Drug Regulatory Affairs; 2016, 4(3), 19-29
. Nadimpalli R, Veeranna B, Teggina MPK, Valluru R. Regulatory guidelines for medical devices in India: An overview. Asian Journal of Pharmaceutics - January-March 2012. Available from: http://www.asiapharmaceutics.info/index.php/ajp/article/viewFile/68/34. Accessed on 20-06- 2017
. www.emergogroup.com/services/india. Accessed on 20-06- 2017
. The Indian Medical Device Industry,Regulatory legal and Tax Overview, Available from: http://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/The_Indian_Medi cal_Device_Industry.pdf. Accessed on 22-06- 2017.
. Shah AR, Goyal RK. Current Status of the Regulation for Medical Devices. Indian J Pharm Sci. 2008 Nov-Dec; 70(6): 695–700
. Medical Device Regulatory Profile for India. Available from: http://www.ita.doc.gov/td/health/indiaregs.pdf. Accessed on 22-06- 2017.
. Amen gross, Update of Medical Device Market in India. Available from: file:///C:/Users/lenovo/Downloads/focus_Oct11_42-49.pdf. Accessed on 24-06- 2017
. Medical Devices and Diagnostics. Available from: http://www.cdsco.nic.in/forms/list.aspx?lid=1580&Id=1. Accessed on 22-06- 2017.
. Medical Devices Making in India - A Leap for Indian Healthcare. March 2016. Available from: http://www.nathealthindia.org/pdf/Deloitte_NATHEALTH_Medical%20Devices%20%20 Making%20in%20India.pdf. Accessed on 23-06- 2017.
. Guidance Document, Medical Device Division. Available from: http://cdsco.nic.in/Medical_div/Final%20Guidance_Doc_Form-28_31- 10-2012.pdf. Accessed on 25-06- 2017
. Chakravarthy I. Medical equipment industry in India: Production, procurement and utilization. Indian Journal of Public Health. 2013;57(4); 203-207.
. Medical devices manufacturing in india- A sunrise segment. Available from: https://www.ibef.org/arab-heatlh- 2017/download/EEPC-IBEF- Arab-Health- Supplement- 30-Jan- 201.pdf. Accessed on 22-06- 2017.
. INDIA – Overview of medical device industry and healthcare statistics. Available from: https://www.emergogroup.com/resources/market-india. Accessed on 22-06- 2017.
. Indian Medical Device Industry –Current state and opportunities for growth Available from: https://www.infosys.com/consulting/insights/Documents/indian-medical- device- industry.pdf. Accessed on 22-06- 2017
. Indian Regulators Publish New Medical Device Rules. Available from : https://www.emergogroup.com/blog/2017/02/indian-regulators- publish-new- medical- device-rules. Accessed on 25-06- 2017
. Health Ministry Notifies Medical Devices Rules, 2017. Available from: http://pib.nic.in/newsite/mbErel.aspx?relid=157955. Accessed on 22-06- 2017.
