REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA
Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 1
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. Keywords
Authors and Affiliations
Vikaas Budhwaar, Yogesh 1Rohilla, Manjusha Choudhary, Prateek kumar
Keywords
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- EP ID EP329243
- DOI 10.22270/ijdra.v6i1.222
- Views 109
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