UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
Recent Blogs
How Does Software as a Medical Device Relate to Unique Device Identification?
Determining Software as a Medical Device is essential for regulatory compliance. This involves classifying software as a Device Component, Accessory, or Standalone Device, and understanding FDA’s UDI requirements and the implications of software changes on device identification.
Is My Product a Medical Device?
A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’....
What is a UDI label and UDI requirements?
Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI). UDI is specific to a device model and version of that device on the market.
Medical Device Classifications in Global Markets and Health Authorities
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements...
FDA GUDID Class I Reminder
(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID?...
EU’s Requirement for Implant Cards Provides Key Information for Patients
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices,...
Updated Survey Shows Most Are Continuing Preparation for EU EUDAMED
Polls conducted May 20, 2021 Survey ResultsAre you as a medical device manufacturer, in the middle of preparing for...
China NMPA UDI and Device Registration Basics
In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation and regulatory submission requirements.
Why You Need a UDI Specialist
Did you know there are multiple health authorities around the globe with current or future requirements for medical...