09Oct Date October 9, 2025 Author Ms. Sneha RamasamyPost-Approval Changes in Medical Devices under CDSCOIntroduction Medical devices continue to evolve even after they receive regulatory approval. Manufacturers frequently implement i...
23May Date May 23, 2025 Author AishwaryaRisk Benefit Analysis in Medical Devices: Beyond DocumentationMedical devices play a vital role in modern healthcare, ranging from simple tools like thermometers to complex systems such as pac...
08Apr Date April 8, 2025 Author AkshayaThe Role of Indian Authorized Agent in Medical Device IndustryThe medical device industry in India has undergone significant transformation and growth over the past few years. This growth is p...
13Feb Date February 13, 2025 Author Mr. Arunkumar ChokkalingamCase 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...
29Jan Date January 29, 2025 Author AishwaryaMD-27 PermssionPurpose MD-26 is the application form used to seek permission from the Central Licensing Authority (CLA) to import or manufact...
03Jan Date January 3, 2025 Author AishwaryaClass 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...