This document outlines the classification system and regulatory requirements for medical devices in Colombia. It discusses four classes of medical devices - Class I being low risk, Class II being moderate risk, Class IIb being high risk, and Class III being very high risk. The classifications are based on the potential risks related to use and failure of the devices. The document also mentions requirements for renewing the sanitary registry for medical devices and outlines valid periods for health surveillance of 10 years.

1. A U T O M A T I C
CLASS I
CLASS IIa
1
2 R E A R C O N T R O L
90 (NINETY) BUSINESS DAYS
CLASS IIb
CLASS III
3 R E N E W A L
THREE (3) MONTHS BEFORE THE EXPIRATION LIMIT OF
THE SANITARY REGISTRY
V I S I T S A N D C E R T I F I C A T I O N S
O F M E D I C A L D E V I C E S
Decree 4725 of 2005
Resolution 4002 of 2007
(Certificate of storage and conditioning capacity- CCAA-
Importers)
C L A S S I F I C A T I O N S
They are based on the potential risks related to the use and
possible failure of the devices based on the combination of
several criteria such as duration of contact with the body,
degree of invasion and local effect versus systemic effect.
(Art. 7)
Health surveillance of medical devices for
human use
VALID FOR 10 YEARS INVIMA
By Daniela Avila
01170021020
C L A S S I
Low-risk medical devices, subject to general controls, not
intended to protect or maintain life or for use of special
importance in the prevention of deterioration of health and
do not represent a potential risk of illness or injury.
C L A S S I I
Moderate risk medical devices, with special controls in
the manufacturing phase to demonstrate their safety
and effectiveness.
C L A S S I I B
High-risk devices, subject to special controls in design and
manufacture to demonstrate their safety and effectiveness
DECREE
4725 OF
2005
C L A S S I I I
Very high risk medical devices subject to special controls,
intended to protect or maintain life or for use of substantial
importance in preventing deterioration of human health, or if
their use presents a potential risk of illness or injury.
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