Submissions and Approvals

India Offers Guidance to Speed Review of IVD Registrations

The Central Drugs Standard Control Organization has issued detailed guidance on the registration, reregistration and import of notified in vitro diagnostic kits and on the import of non-notified kits, with the aim of speeding submission reviews and easing the move to electronic submissions. Read More

FDA Clears EarlySense Bedside Monitor

The FDA has granted 510(k) clearance for Israel devicemaker EarlySense to market an updated version of its EarlySense bedside monitoring system, the company announced Wednesday. Read More

India Offers Detailed Guidance on Registration, Import of IVDs

India’s Central Drugs Standard Control Organization has issued detailed guidance on submission requirements for the registration, reregistration and import of notified in vitro diagnostic kits and import of non-notified kits, with the aim of facilitating application reviews and easing transition to electronic submissions. Read More

EC Pilot Looks to Speed Coverage of Promising New Technologies

The European Commission is launching a pilot program to help devicemakers better understand the kinds of clinical evidence health technology assessors need to make coverage decisions, in the hopes of avoiding last-minute conflicts as companies bring products to market. Read More

Year in Review: Devicemakers Ride Regulatory Roller Coaster Into 2014

Regulatory affairs folks had little time to relax in 2013, with heated debates over the future of EU device regulations, new controls in Japan and a proposed regulatory framework in India. And that’s just the tip of things. During the year, Malaysia got busy implementing its new device law and Brazil eased the process for device registration. Members of the International Medical Device Regulators Forum cemented plans for a January launch of a single-audit pilot program, and the U.S. Food and Drug Administration finalized rules for unique device identification. Use this review to reflect on developments in 2013 and prepare a winning business strategy in 2014. Read More