Study of Barriers to the Implementation of New Legal Framework for Medical Devices using Content Analysis

Abstract

Background: The article starts with a short explanation of medical devices, their critical role in the treatment, and the need to control their quality through a legal framework by the authorities.  The companies in this sector are relatively smaller. The government has proposed a legal framework for regulating the industry, but its implementation is in flux due to possible barriers.

Objectives: The objective of the study is to understand the barriers to implementing a new legal framework through Quantitative and Qualitative techniques, primarily content analysis.

Method: 64 high-level industry representatives were interviewed, and the transcripts of the interviews were recorded and analysed using SPSS and NVivo programs.

Results: An equal number of respondents found it difficult and easy to implement the new regimen. Further analysis revealed that the level of ease or difficulty was not associated with the company’s size, life and complexity of the product basket.

Conclusions: CDSCO is coming out as a bottleneck. However, one more important cause was reported in Content Analysis, namely, lack of knowledge of the new regimen implementation and familiarity with the legal framework by the companies. There is a need for training for the companies. Platforms and methods for training CDSCO staff, as well as medical device companies on the new legal framework are recommended.