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...