International Journal of Drug Regulatory Affairs (IJDRA)

  • Year: 2018
  • Volume: 6
  • Issue: 1

Regulations of registration and import of medical device in India

  • Author:
  • Vikaas Budhwaar1,, Yogesh Rohilla1, Manjusha Choudhary2, Prateek Kumar3
  • Total Page Count: 5
  • Page Number: 8 to 12

1Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana (India)

2Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra, Haryana (India)

3Chamber No. 126, District Court Complex, Rohtak, Haryana (India)

*Corresponding Author's E-mail: vikaasbudhwar@yahoo.com

Online published on 17 September, 2019.

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

Medical devices, Regulation, Import, Registration