Class C Medical Device Import License in India – MD-14, MD-15, MDR 2017 & CDSCO Approval Guide
Class C Medical Device Import License in India Common Mistakes Under MDR 2017 — Practically Explained By Ankur K. Khare – Biomedical Engineer | Regulatory Affairs Specialist | Founder – RegIntel Med India Importing a Class C medical device in India is not just an application. It is a regulatory strategy decision. Under the Medical Device Rules (MDR) 2017 , Class C devices fall under moderate-to-high risk, meaning: Your documentation depth increases CDSCO scrutiny intensifies Approval timelines expand Query handling becomes critical Most delays in Class C import license applications (MD-14 / MD-15) happen due to preventable strategic mistakes. This article explains those mistakes practically — not just legally. Why Class C Import Applications Face Higher Scrutiny For Class C medical device import in India: ✔ Application is filed in Form MD-14 ✔ License is granted in Form MD-15 ✔ Device Master File (DMF) is mandatory ✔ Plant Master File (PMF) is required ✔ Indian Authorized Agent is co...