Australian Unique Device Identification (UDI) Framework: Medical Device UDI Implementation, Essential Principles Guidance
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.
Unlocking & Empowering your Understanding of the Global Data Synchronization Network (GDSN) – Part 2
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 a big difference,...
Unlocking & Empowering your Understanding of the Global Data Synchronization Network (GDSN) – Part 1
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).
FDA Issues Final Guidance on UDI Compliance Requirements and Extends Enforcement Deadline
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 Identification: Policy Regarding...
Let us help you on the path to UDI Compliance for FDA with Innovit’s GUDID Reference Center
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?
We’re Excited To Be Back In Person! Announcing Innovit’s 2022 Event Calendar
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’ in-person events – so we...
FAQ: Global Unique Device Identification Database (GUDID)
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 component of the...
Start your Class I FDA GUDID data submission journey with these initial steps!
It’s hard to believe we’re more than halfway through January! You should be thinking and planning for the FDA’s GUDID compliance deadline for Class I medical devices. September 24, 2022 is just around the corner! Time certainly flies – and even with the...
Introducing Innovit’s EUDAMED Reference Center
As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices. Even the most experienced companies uncover critical gaps in...
Innovit’s 2021 Recap and a Look Ahead!
2022 is almost here and the holiday season is in full flight! As another turbulent year comes to an end, the team at Innovit took a moment to reflect on the past year while also looking ahead with zeal and optimism. Though agility and adaptability are nothing new...