A Review of Registration and Approval Process of Medical Device in India and Japan

  • Shubham N. Kumavat Department of Regulatory Affairs, SNJBs Shriman Sureshdada Jain College of Pharmacy, Neminagar, Chandwad, 423101, Dist. Nashik, Maharashtra, India.
  • Lokesh P. Kothari
  • Atish S. Mundada

Abstract

Today, millions of people rely on medical device-based treatment to manage and diagnose a variety of disorders. The regulatory requirements determine the device's quality and safety. Because of the enormous population and the potential severity of the consequences of introducing inferior and dangerous materials to the market, medical device production in India should be regarded seriously. As a result, a legislation including suitable guidelines for rules and regulations is required to monitor the introduction of such devices into public health use. Currently, the regulatory body CDSCO governs device regulation in India, and amendments to the law will give public health safety ensure over time. In Japan, pharmaceutical regulatory affairs are overseen by the Ministry of Health, Labor, and Welfare (MHLW or Koseirodosho in Japanese). Formal authorization and licenses obtained from the MHLW are required for drug marketing in Japan. The regulatory plans are one of the most difficult components of launching a medical device because every medical device is unique. Every significant market, such as India and Japan, has its own specific set of legal requirements. Understanding the critical need for national standardization in order to reduce regulatory burdens, ease commerce, and provide access to innovative technology requires more research.

Keywords: Medical device, Drug and Cosmetic Act 1940 and Rules 1945, CDSCO, MHLW, PMDA, QMS, MAH, Registration process for medical device

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How to Cite
Kumavat, S. N., L. P. Kothari, and A. S. Mundada. “A Review of Registration and Approval Process of Medical Device in India and Japan”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 4, Dec. 2023, pp. 16-24, doi:10.22270/ijdra.v11i4.628.