A Comparative Study of Medical Device Regulation in US and India

  • Deepika Sagar Department of Drug Regulatory Affairs, Chandigarh College of Pharmacy, Landran, Mohali, (Punjab), India 140307
  • Priyanka Gupta


Articles, instruments, apparatuses, or machines used in the prevention, diagnosis, or treatment of illness or disease, or for detecting, measuring, restoring, correcting, or modifying the structure or function of the body for some health purpose, make up the medical technology industry (commonly referred to as medical devices).

Medical supplies India's medical market is one of the top twenty in the world. By 2025, it is estimated to be valued $5.2 billion. India produces very little medical equipment and currently imports more than 70% of its medical supplies. In India, medical devices were governed by The D&C Act is a federal law that regulates the sale of drugs and cosmetic of 1940, which included specific medical device laws. India Medical Device Rules 2017, which are new medical regulations in India, were issued to fill this hole by the CDSCO. There are many doctors and pioneers in the field.

On the other hand, the United States continues to be the world's largest medical device market, with $156 billion in sales. It is estimated to reach $208 billion by 2023. In 2018, the United States exported $43 billion worth of medical equipment in key product categories specified by the Department of Commerce.

Keywords: Medical device, FDA, CDSCO, Regulatory requirement, D&C Act, USFDA


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How to Cite
Sagar, D., and P. Gupta. “A Comparative Study of Medical Device Regulation in US and India”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 1, Mar. 2022, pp. 83-87, doi:10.22270/ijdra.v10i1.511.