by Innovit Corporate Affairs | Sep 28, 2020 | Blog, GUDID
As a medical device manufacturer, you are required to submit product data to the GUDID in order meet UDI compliance requirements. If your company markets relatively few products in America, you may simply choose to do so by uploading spreadsheets directly to the...
by Innovit Corporate Affairs | Sep 16, 2020 | Blog, UDI
Despite frequent and rapid changes in the regulation process, companies cannot ignore the value of bringing medical devices to the Chinese market. It is a potential high-growth area for many global medical device manufacturers. So, if you’re a medical device...
by Innovit Corporate Affairs | Sep 8, 2020 | Blog, Eudamed, GUDID
The European Database for Medical Devices (EUDAMED) EU MDR, the European Union’s Medical Device Regulation is intended to support both pre-market product registration processes and post-market surveillance & vigilance activities by national regulators across the...
by Innovit Corporate Affairs | Jul 7, 2020 | Blog, UDI
The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices. Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for...
by Innovit Product Team | Apr 19, 2020 | Blog, GUDID, UDI
The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every medical device with an identifier. Unique Device Identification (UDI) is a system to mark and identify medical devices (via...