Regulations of registration and import of medical device in India Budhwaar Vikaas1,*, Rohilla Yogesh1, Choudhary Manjusha2, Kumar Prateek3 1Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana (India) 2Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra, Haryana (India) 3Chamber No. 126, District Court Complex, Rohtak, Haryana (India) *Corresponding Author's E-mail: vikaasbudhwar@yahoo.com
Online published on 17 September, 2019. Abstract India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical device in India. If a company which wants to imports its medical devices in India does not have a registered office in India it needs Indian agent authorized by CDSCO, to do so. Duly filled form-10 is required to be submitted for import license, while form-44 duly filled is required to be submitted for marketing authorization of a new medical device or its reregistration. The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned. Top Keywords Medical devices, Regulation, Import, Registration. Top |