medical device

Global Medical Device Nomenclature

"The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. Such products include those used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The main purpose of the GMDN is to provide health authorities and regulators, health care providers, medical device manufacturers and suppliers, conformity assessment bodies and others with a single generic naming system that will support patient safety.

Global InVitro Diagnostic Classification

"An effective product classification system is critical to the functioning of any industry in the knowledge-based markets of today. A classification scheme assigns a code to each product type or class, allowing quick identification of the product in a language-independent fashion (the specific name of the product is actually not mentioned).

"An effective product classification system is critical to the functioning of any industry in the knowledge-based markets of today. A classification scheme assigns a code to each product type or class, allowing quick identification of the product in a language-independent fashion (the specific name of the product is actually not mentioned).

Product Classification

"The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device."