Oct 12, 2023
Canada
This article highlights he current regulations for medical devices in Canada, the process of registering compliant devices, potential changes being considered, and the potential impact on stakeholders. Table of Contents The use of medical devices is essential in...
Read More
Oct 10, 2023
Asia
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
Read More
Oct 4, 2023
CDRH
This blog post will provide an overview of the GUDID, its purpose, how it works, and its impact on the healthcare industry. Table of Contents The FDA’s Global Unique Device Identification (UDI) Database is a pioneering initiative that has revolutionized the...
Read More
Aug 16, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices’ regulations, has published a guidance document dedicated to the integration of the UDI within an organization’s quality management system. Table...
Read More
Aug 5, 2021
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices regulations, has published a guidance document dedicated to the integration of the UDI within organizations’ quality management systems. The MDCG...
Read More