OBJEctive of law

Regulates the system of health records, marketing permits and health surveillance of
medical devices of human use

Definition
Is any instrument, apparatus, implement, machine, appliance or
othe similar or related, usinhg alone or in combination.
Including its components, accessories, parts and computer
programs thet intervene the proper functioning for theuse in
humans.
Medical devices are classified intro
• Class I
• Class IIA
• Class IIB
• Class III
• Invasive, non-invasive and fraudulent medical devices.
 Class I
They are those low risk medical devices that are subject
to general controls, not intended to protect or keep the
lifetime human or a only use from importances in
preventing health deterioration and does not reperesent
an unreasonable potencial risk of illness or injury.

Class IIA
Are those Medical devices from risk moderated subject to
special controls at the manufacturing stage to
demonstrate its safety and effective.

Class IIB
They are those high risk medical devices subject to controls
specials on his design and manufacturing for demonstrate
its safey and effectiveness.

Class III
Are those devices doctors from very high risk subject to
special controls, intended toprotect or sustanin life or for
use of substantial importance in the prevention of the
deterioration of human health, or if its use presents a
potential risk of illness or injury.
 DISPOSITIVOS MEDICOS INVASIVOS DISPOSITIVOS MEDICOS NO
Is that device what penetrative INVASIVOS
partially or complete inside of the body They are those who do not break
through is body orifice or trough the the skin or do not physically
body surface. penetrate the skin

DISPOSITIVOS MEDICOS FRAUDULENTO

They are those that are marketed whitout
complying with what is required in the technical
and legal provisions that do not regulate, or one
that is totally assembled or partially on Colombia
whitout the record marketing health.

Health registrer

It is the document issued by the corresponding health authority

(INVIMA), through which it authorizes a natural or legal person to
manufacture, package and import food and/ or medicines with
destination for human consumption.

¿What does the labelo f a medical device contain?

Suture Name Sterilization method
Do not re-sterilize

Caracteristics: Lot
Color, composition
andstructure.
Manufacturing date

Health registrer Due date

Maker of medical
devices Manufacturing information
 GRUPO # 5

Valentina García
Cristian Ardila
Consuelo Cárdenas
Dayana de León
Laura Álvarez
Valeria Gualdrón
Wendy Rios
Marlyn Turizo

CARDIOVASCULAR, HEMODINAMICS
AND ELECTROFISIOLOGY

2022-A