Patients are entitled to the best care.
Historically, healthcare has been a strongly regulated sector that follows national solutions. With an increasingly mobile world population, harmonising standards is critical.
The use of GS1 global standards in healthcare can:
Leverage our deep experience in the healthcare industry to solve complex policy issues.
Counterfeit drugs have become an increasing global threat over the last few decades and more and more regulatory authorities, including Argentina, Brazil, India, South Korea, Saudi Arabia and the EU, have adopted or will adopt requirements for the use of globally unique drug identifiers and serialisation in order to protect the supply chain.
The Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain.
The IMDRF (International Medical Device Regulator Forum) and other regultors across the world are aiming for a globally harmonised and consistent approach to increase patient safety and help optimise patient care by proposing a harmonised legislation for Unique Device Identification (UDI), using global standards.
On 17 December 2013, GS1 has been accredited by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs).
This database provides the latest relevant regulatory requirements, stakeholder agreements and user requests related to Healthcare product identification, product catalogues and traceability at national, regional and local levels. It contains information received by the worldwide network of over 112 GS1 Member Organisations (MOs), members of the global GS1 Healthcare community, and governmental bodies and regulators involved in the Healthcare sector.
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