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Technical Concepts
Medical equipment and materials or "medical devices" are appliances,
materials or accessories whose use or application is related to safeguarding
individual or collective health, to personal hygiene or cleanliness of
surroundings, or to diagnostic and analytical purposes, to cosmetics and
perfumes, as well as to dietetic, optical, medical acoustic, odontology
and veterinary products.
Medical devices, for the purposes of enforcement of sanitary legislation,
comprehend the following products defined in Administrative Rule MS 2.043,
of December 12, 1994 and Administrative Rule SVS 686, of August 27, 1998:
Definitions of Medical Devices
> Diagnostic equipment
Medical, odontologic or laboratory appliance, apparatus or instrument
used for detecting information from the human body for the purpose of
assisting clinical procedures.
> Therapy equipment
Medical or odontologic appliance, apparatus or instrument used for treatment
of pathologies, including substitution or modification of the anatomy
or physiological process of the human body.
> Medical-hospital support equipment
Medical, odontologic or laboratory appliance, apparatus or instrument
used to provide support to diagnostic, therapeutic or surgical procedures.
> Disposable materials and devices
Medical, odontologic or laboratory materials and devices intended to be
used only once, temporarily or for a short time.
> Implantable materials or devices
Medical or odontologic materials and devices, intended to be introduced
totally or partially, through medical procedure, into the human body or
natural orifice of the human body, or intended to replace an epithelial
surface or eye surface, remaining for a long time inside the body after
the procedure, and removable only through surgical procedure.
>Medical-hospital support materials and devices
Medical, odontologic or laboratory materials and devices intended to provide
support to diagnostic, therapeutic or surgical procedures.
> "In-vitro" diagnostic products
Reagents, instruments and systems that, together with their instructions
for use, contribute to the undertaking of a qualitative, quantitative
or semi-quantitative assessment of a biological specimen, and that are
not intended to fulfil any anatomical, physical or therapeutic function
and are used exclusively to provide information about specimens collected
from the human body.
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