Open AccessREGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA
Author(s) -
Vikaas Budhwaar,
Yogesh Rohilla,
Manjusha Choudhary,
Prateek Kumar
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/journal.v6i1.222
Subject(s) - license , certificate , business , authorization , medical device , commerce , medicine , computer security , political science , law , computer science , algorithm , biomedical engineering
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 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.