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Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements and guidelines for active medical devices.
In a global, data-driven and digital world, standardizing, mastering and leveraging high volumes of master data in an automated process is a strategic and business imperative.
Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001.
Australia is establishing a unique identification system for medical devices and its regulator, the Therapeutic Goods Administration (TGA) issued several updates regarding Unique Device Identification (UDI) regulations, Essential Principles for compliance requirements and guidelines for active medical devices.
Getting Started With the GDSN In our previous blog, we discussed what the GDSN is. In today’s blog, we’ll go over what companies can expect and should prepare for when starting their GDSN journey. As with any journey, how you start can make...
Sharing information about products and devices is a cornerstone of modern supply chains, regulatory compliance departments and ecommerce platforms. There are several options to facilitate this sharing, from point-to-point implementations to more dispersed methods that allow multiple connections to utilize the same information, such as the Global Data Synchronization Network (GDSN).
On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The guidance document, “Unique Device...
Are you preparing for the FDA’s enforcement of UDI labeling and GUDID (Global Unique Device Identification Database) data submission requirements for Class I and unclassified devices, coming up in September 2022?
As we look ahead with optimism to traveling again in the coming year, with some expected bumps along the way, we’re thrilled to share Innovit’s return to in-person events in 2022! No doubt we’ve all gained some new appreciation for ‘real’...
What is GUDID? GUDID is an acronym for the Global Unique Device Identification Database — a central repository of detailed medical device information created by the US FDA. It is often pronounced “Good ID”. The GUDID system was implemented as a...