Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 2)
Welcome back! If you missed our 2022 re-cap in part one of this blog series, you can find it here. If you’re already caught up…
Onward! A Review of 2022 Meets an Exciting Outlook for 2023 (Part 1)
We couldn’t be more excited about 2023, but before we move forward, let’s take a look back at all our accomplishments.
So, let’s wrap up the incredible, unpredictable and unprecedented year 2022 with the eyes of a winner!
FDA Class I GUDID Compliance Regulation FAQ’s
Medical Device Manufacturers in the US have many questions as the Dec 8, 2022 GUDID compliance deadline approaches. This blog will answer some of the most common questions, and ensure everyone has the answers they need to begin their journey toward the FDA’s GUDID Class I Compliance.
9-Steps to GUDID Class I Medical Device Compliance
The FDA will enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, on December 8, 2022.
Brazil’s UDI Update: ANVISA plans major medical device registration updates
Brazil’s medical device market regulator, ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001.
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 […]
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, […]
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?