Hi Julie, To give an example, Intravenous (IV) set is a device that required product registration in India since 2010 as according to their notified Medical Device List. However, my previous marketing team told me there is a lot of un-registered IV set available in India market sold by other company which didnt go through hassle of product registration...

It was great meeting some of you at the RAPS Convergence 2016 in San Jose, CA, last week, and hear some of the challenges regulatory professionals outside of the US face when trying to get a local RAPS Chapter or Local Networking Group going. Therefore I commend you all for staying dedicated to the cause. So what's next? Is anyone interested in having...

One of the purposes of the new regulation is to harmonize the US device labeling requirements with international regulatory requirements. The FDA currently recognizes a list of standards that contain a limited number of stand-alone symbols. These standards are: ISO & ANSI/AAMI/ISO 27185 - Symbols to be used with cardiac rhythm management...