About Medical Device

Medical devices, when used in humans, do not provide their primary function with pharmacological, immunological or metabolic effects, but can be supported by these effects while performing the function, and on humans;

Diagnosis, prevention, monitoring, treatment or alleviation of disease,
Diagnosis, monitoring, treatment, mitigation or redress of injury or disability,
Investigation, modification or replacement of an anatomical or physiological function,
All kinds of tools, instruments, equipment, software, including software that is manufactured for birth control purposes, can be used alone or in combination, especially for diagnostic and/or therapeutic use by the manufacturer, and is necessary for the medical device to perform its intended function, includes accessories or other materials.

Medical devices can be grouped under 3 main headings, as they have a very wide definition area.

Active Medical Devices; Medical devices powered by any electrical energy or power source other than gravity or the energy naturally generated by the human body. For example, Ultrasound devices, x-ray equipment, etc.
Active implantable medical devices; Active medical devices that are inserted, in whole or in part, into the human body or a natural body cavity or cavity by medical or surgical intervention and must remain in place. For example, Pacemakers, Diffusion pumps used in Oncological applications, etc.
Investigation, modification or replacement of an anatomical or physiological function,
In-vitro medical devices; The incorporation of specimens from the human body, including blood and tissue donations, whether used alone or in combination, by the manufacturer principally for the purpose of obtaining information about physiological or pathological condition or Congenital anomalies, or to determine suitability and safety for prospective recipients or to monitor treatment. All medical devices that are reagents, reagents, calibrators, control materials, kits, instruments, instruments, equipment or systems designed for in vitro examination, and specimens taken from the human body for in-vitro medical diagnostic examination, whether or not they have vacuum properties or not. Sample containers used for storage and storage, Personal test device: Devices produced by the manufacturer in a way that can be used by any person in the home environment. For example, reagents used in pregnancy test, reagents used in blood group determination, reagents used in AIDS diagnosis, sample containers used in the transportation and preservation of human body samples, injectors, blood bags, wound care products, surgical threads, etc.