A Review on Approval Process and Regulation of Medical Devices as per US FDA and CDSCO

  • Kaustubh Navnath Pawar NA
  • Rohit Tukaram Gore
  • Samiksha Rohidas Palekar


Regulatory affairs play a significant role in the pharmaceutical industry, it is “the process of gathering, reviewing, and monitoring the existing regulatory environment and creating regulatory plans and gaining a competitive edge for securing regulatory approvals required more than just acquiring facts”. A medical device is a treatment instrument that "does not work on or in the human body in a way that is primarily intended by pharmacological, immunological, or metabolic mechanisms”. In other words, a medical device is essentially any medical product, not a medicine or biological product. By the Drugs and Cosmetics Act, Central Drugs Standard Control Organization (CDSCO) oversees approving drugs, conducting clinical trials, setting standards for drugs, monitoring the quality of drugs imported into the nation, and coordinating the efforts of state drug control organizations by offering professional advice to ensure uniformity in the application of the Drugs and Cosmetics Act. The US Food and Drug Administration (FDA), a single agency, oversees the regulation of a trillion dollars’ worth of goods, or about 25 cents of every dollar spent, including 80 percent of the food supply in the US, all medical devices, and prescription drugs, animal products, cosmetics, and even the production of tobacco products. The FDA's Center for Devices and Radiological Health regulates companies that produce, repackage, re-label, and/or import medical devices sold in the United States (CDRH). Also, CDRH is in charge of overseeing the regulation of lasers, x-ray machines, ultrasound equipment, microwave ovens, and color televisions, among other electronic gadgets that generate radiation for both medical and non-medical purposes. The IMDR, which was published in January 2017 and became effective in January 2018, was produced by the Medical Devices and Diagnostics Division of CDSCO and is a set of structured regulations for medical devices. In February 2020, the "Medical Devices (Amendment) Regulations, 2020" were established, and they became effective in April 2020. The 2020 amendment now includes a new clause called "registration of specific medical equipment."

Keywords: Regulatory affairs, Central drug standard control organization (CDSCO), Food and drug administration (FDA), Medical devices, Medical devices Regulation, CDRH, EMEA, Sugam online portal


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How to Cite
Pawar, K. N., R. T. Gore, and S. R. Palekar. “A Review on Approval Process and Regulation of Medical Devices As Per US FDA and CDSCO”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 1, Mar. 2023, pp. 61-70, doi:10.22270/ijdra.v11i1.586.