News/Updates

Deadline Alert for CDSCO Class C & D Medical Device License The Ministry of Health & Family Welfare (MoHFW) issued a notification, on February 11, 2020, categorizing all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, with effect from April 1, 2020.  To ensure the […]

FDA’s Move to Regulate Laboratory Developed Tests as Medical Devices In a significant development, the US Food and Drug Administration (FDA) has introduced a groundbreaking rule change that will impact the regulation of Laboratory Developed Tests (LDTs) and In Vitro Diagnostic Products (IVDs). Under these new regulations, LDTs are set to be classified and regulated

Draft on Best Practices for Selecting Predicate Devices for FDA 510(k) Notification On September 6, 2023, the US Food and Drug Administration (FDA) took a significant step towards enhancing and modernizing the 510(k) Program, aimed at providing greater predictability, consistency, and transparency in the 510(k) premarket review process. Specifically, the FDA released a set of

Education Scheme for the Medical Device Sector The government has given the green light to a ₹480 crore initiative aimed at nurturing a skilled workforce to propel the growth of the medical devices industry. This three-year scheme is set to offer financial support to government institutions, enabling them to offer a range of courses related

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

Brief Update on: India to Become Self-Sufficient in Medical Devices By 2030, India will require $50 billion in medical devices. If the native industry does not expand owing to technological or policy constraints, large-scale imports will fill the gap. It is time for India to capitalize on its strengths, strengthen local production, and cement its

India’s government nears the launch of a pivotal national policy aimed at fueling research, development, and innovation within the pharmaceutical and medical devices sectors, according to Union Health Minister Mansukh Mandaviya. Speaking at the G20 health ministers meeting in Gandhinagar, Mandaviya emphasized India’s healthcare vision, transitioning from volume-based approaches to a value-based leadership model. This