REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA

Vikaas Budhwaar, Yogesh Rohilla, Manjusha Choudhary, Prateek Kumar
2018 International Journal of Drug Regulatory Affairs  
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
more » ... ly filled is required to be submitted for marketing authorization of a new medical device or its re-registration. 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.
doi:10.22270/journal.v6i1.222 fatcat:shgwijnh3bhbbi7dxyce7hfncm