08 Apr Date April 8, 2025 Author Akshaya The Role of Indian Authorized Agent in Medical Device Industry The medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
13 Feb Date February 13, 2025 Author Mr. Arunkumar Chokkalingam Case Study 1: U.S. Endotracheal Tube Manufacturer – Achieving 21 CFR 820 Compliance & 510(k) Submission with Medfins International. Client Background This case study focuses on a U.S.-based medical device manufacturer specializing in endotracheal tubes. The c...
29 Jan Date January 29, 2025 Author Aishwarya MD-27 Permssion Purpose MD-26 is the application form used to seek permission from the Central Licensing Authority (CLA) to import or manufact...
03 Jan Date January 3, 2025 Author Aishwarya Class A and B notified medical device manufacturing registration in India. Government Authority (CDSCO) The Central Drugs Standard Control Organisation (CDSCO), a Ministry of Health & Family Welfare...