• Vikaas Budhwaar
  • Yogesh Rohilla
  • Manjusha Choudhary
  • Prateek kumar


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.

Keywords: Medical devices, Regulation, Import, Registration


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How to Cite
Budhwaar, V., Y. Rohilla, M. Choudhary, and P. kumar. “REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 1, Mar. 2018, pp. 8-12, doi:10.22270/ijdra.v6i1.222.