India's Medical Device Market: Your Guide to the Authorized Agent Requirement

Medical Device Global Market Access · Oct 15, 2025 · 3m

This episode breaks down the essential role of the Authorized Indian Agent (AIA) for medical device companies entering the Indian market. We explore the regulatory framework under the CDSCO, the specifics of the MD-14 and MD-15 forms, and the critical strategic considerations when appointing your in-country representative. • What is an Authorized Indian Agent (AIA) and why is it mandatory in India? • How do Forms MD-14 and MD-15 govern the medical device import license process? • What are the key responsibilities of an AIA beyond the initial registration? • Can a distributor act as an…