Global Medical Device Nomenclature: Basic concept and Five-Year strategy

  • Ayesha Siddikha
  • K. S. L. Vidyadhari
  • M. Beulah Manasa
  • N.L. Prasanthi
  • K. Venkateswara Raju ASSISTANT PROFESSOR

Abstract

Many people are involved in the medical device industry and their motto is to ensure the safety of medical devices, while having very varied roles and levels of process knowledge. For the first time, Global Medical Devices Nomenclature (GMDN) enables an international system to identify all medical devices generically. The GMDN now enables, for the first time, an international system for generically identifying all medical devices in a helpful way to all users. Many nomenclature systems were in existence before the GMDN, all of which were based on various structures and had been used locally or nationally for unique objectives using different techniques. In this article we are explaining the basic concept of GMDN, importance of naming, the need of GMDN, global acceptance. GMDN term structure involves finding codes and searching for GMDN terms. In addition, there will be an explanation of the Unique Device Identification (UDI) and UDI requirements carrier & hardware relationship between UDI and GMDN. Finally, the five-year strategy (2022-2026) focuses and sets out an ambitious vision for growth and increased global harmonization. The strategies set out in specific programs of work that will drive development in the coming years are also mentioned.

Keywords: Medical devices, Nomenclature, Global medical device nomenclature, Unique Device Identification, five-year strategy

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How to Cite
Ayesha Siddikha, K. S. L. Vidyadhari, M. B. Manasa, N. Prasanthi, and K. Venkateswara Raju. “Global Medical Device Nomenclature: Basic Concept and Five-Year Strategy”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 38-44, doi:10.22270/ijdra.v10i4.560.