Operon Strategist

Electronic Export Documents for Medical Device (CDRH) is ushering in a significant change in the way export documents for medical devices are handled. Effective January 2, 2024, the transition from traditional paper documents to electronic export documents will commence. These electronic documents will encompass several essential certificates, including: Certificate to Foreign Government Certificate of Exportability […]

Medical Technology Industry Voices Concerns in Open Letter to European Commission In a significant development, the European medical technology industry has issued an open letter to the European Commissioner for Health and Food Safety, Stella Kyriakides, urging regulatory changes. The industry expresses its reservations regarding the current Medical Devices Regulation (MDR) and the In Vitro

Medical Device Park: At Nagalpar, Rajkot The Government of Gujarat is developing a state-of-the-art Medical Device Park in Nagalpar, near Rajkot, spanning 250 acres, with a central financial grant of ₹250 crore. This flagship initiative is scheduled to be fully operational by the end of 2024. Strategically planned to promote domestic medical device manufacturing, the

The Central Drugs Standard Control Organization (CDSCO) is currently in the process of reviewing a comprehensive report submitted by a task force to the Drugs Controller General of India (DCGI). This report holds significant implications for the enhancement of laboratories engaged in the testing of medical devices. Government’s Emphasis on Quality Infrastructure for Medical Device