Why CDSCO Rejects MD-14 Import License Applications — Real Reasons + How to Avoid Rejection
Why CDSCO Rejects MD-14 Import License Applications — Real Reasons + How to Avoid Rejection By Ankur K. Khare – Biomedical Engineer | Regulatory Affairs Specialist | AI Ethics & Medical Innovation Form MD-14 rejection by CDSCO is one of the most common regulatory bottlenecks for medical device importers in India. Based on real scrutiny patterns, this article explains the top MD-14 rejection reasons and how to avoid them. Importing medical devices into India legally requires approval under Form MD-14 , followed by grant of an import license in Form MD-15 from the Central Drugs Standard Control Organization (CDSCO). When done correctly, this license enables legal customs clearance and distribution of devices across India. However, a surprisingly high number of MD-14 applications are rejected at the CDSCO scrutiny stage , leading to delays, increased costs, and supply disruptions for manufacturers and importers. Understanding the real reasons behi...