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

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 Authorized Indian Agent? • What are the risks of tying your import license to a single commercial partner? • Why is the MD-15 license non-transferable, and what does this mean for your business? • How can you maintain commercial flexibility with multiple distributors? • What qualifications must an entity have to become an AIA? • What is the role of the CDSCO's Medical Device Rules, 2017, in this process? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.