9-Steps to GUDID Class I Medical Device Compliance
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 FDA will enforce the GUDID submission requirements for Class I and...
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. The changes will serve to strengthen the country’s medical device registration regulations upon their effective date of...
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...
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,...