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 94
  • Downloads 0

How To Cite

Vikaas Budhwaar, Yogesh 1Rohilla, Manjusha Choudhary, Prateek kumar (2018). REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA. International Journal of Drug Regulatory Affairs, 6(1), 8-12. https://europub.co.uk/articles/-A-329243