Medical Device Regulation in India: Comparative Stakeholder Analysis and Policy Recommendations for CDSCO

Objectives

India's rapidly growing medical device industry, which is expected to rank among the biggest in the world in the next ten years, is heavily regulated by the Central Drugs Standard Control Organization (CDSCO). Significant obstacles are still being reported by stakeholders in a variety of roles and geographical areas, even after significant regulatory advancements were made in 2017 with the implementation of the Medical Device Regulations (MDR).

Materials and Methods

To find statistically significant gaps, SPSS-based tests such as ANOVA, Chi-square, and Pearson correlation were performed.

Results

In comparison to international benchmarks (FDA 4.1, EU MDR 4.3), a national average of 2.9 was found using a Regulatory Satisfaction Index (RSI). The findings showed gaps in knowledge depending on roles and zonal imbalances. Classification clarity and registration success were shown to be strongly correlated (r=0.72, p<0.001). The model which includes risk-based classification, electronic submissions, feedback mechanisms, integrated surveillance, national training, and enforcement (REFINE) is proposed in this study as a solution to these issues.

Conclusion

These suggestions may be to improve compliance, simplify India's regulatory framework, and solidify its place in the world of medical technology. The results provide CDSCO and stakeholders with a useful, evidence-based policy roadmap.