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Suspension of Legal Terms by INVIMA and Temporary Closure of Public Services (December 2024)
INVIMA issued Resolution No. 2024057693 , dated December 17, 2024 , through which it has announced the suspension of legal terms for...
SVip
Dec 17, 20241 min read
7 views

Changes on a label: Are they annexes to the dossier or formal modifications?
For medical devices or reagents, label changes can either be minor updates or formal modifications, each with different reporting...
SVip
Oct 29, 20241 min read
3 views

LIST OF PERMITTED MODELLING SUBSTANCES
Introduction  Since the enactment of Law 2316 of 2023, the Ministry of Health and Social Protection and INVIMA have conducted various...
SVip
Sep 10, 20242 min read
2 views

CCAA to obtain a registration in Colombia is it important?
Obtention of a license to commercialize a Medical Device or an In Vitro Device (MD or an IVD) in Colombia includes the provision of legal...
SVip
Jul 10, 20241 min read
36 views
Watches that measure vital signs are considered Medical Devices.
MD Specialized Board from INVIMA deemed that bracelets (watches, bands, etc.) measuring heart rate and other variables such as oxygen...
SVip
May 10, 20241 min read
2 views
Some intimate gels, creams and lubricant products are Medical Devices and some others are not.
If their composition and indication for use is exclusively to lubricate intimate areas, they are considered medical devices class I If...
SVip
May 10, 20241 min read
1 view
UDI-DI What happens to MDs/IVDs that are already registered? February 2024 is here.
If the product is already registered, the UDI-DI code must also be registered. INVIMA established the following times according to the...
SVip
Feb 15, 20241 min read
21 views

FACT CHECK
As part of the dossier to be submitted at INVIMA for registration purposes, a Free Sales Certificate - FSC- (Certificate of Foreign...
SVip
Sep 26, 20231 min read
17 views

Unique Device Identifier (UDI) for MDs and IVDs to be implemented in Colombia as from 2024
The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and...
SVip
Jun 9, 20231 min read
445 views

INVIMA´s server is unavailable and legal terms have been suspended.
INVIMA issued Resolution No. 2022600000/2022 whereby it decided to suspend legal terms in all on-going processes (requirements, writs,...
SVip
Oct 5, 20221 min read
12 views

Semantic standard and coding for Medical Devices and IVDs in Colombia
Colombian Ministry of Health issued Resolution No. 1405/2022 by which it decided to implement a semantic standard and coding for medical...
SVip
Aug 22, 20221 min read
121 views

Sanitary Emergency extended in Colombia until June 30, 2022
Colombian government decided to extend the Sanitary Emergency. This means that products declared by INVIMA as vital non available (also...
SVip
Apr 29, 20221 min read
6 views

INVIMA is back to normal!
Today April 1, 2022 a ll services have been reestablished
SVip
Apr 1, 20221 min read
2 views

INVIMA issued Resolution 2022500009: It suspends legal terms and reestablishes some services.
INVIMA issued Resolution No. 2022500009/2022 by which it modifies former resolutions and suspends legal terms until March 31, 2022. The...
SVip
Mar 18, 20221 min read
12 views

INVIMA extends suspension of legal terms and reestablishes a few services
INVIMA issued Resolution No. 2022500005/2022 by which it modifies former resolutions and suspends legal terms until March 17, 2022. The...
SVip
Mar 9, 20221 min read
7 views

INVIMA: gradually reestablishing services. Suspension of legal terms are extended until March 9, 202
INVIMA issued Resolution No. 2022500003/2022 by which it modifies former resolutions and suspends legal terms until March 9, 2022. Some...
SVip
Feb 28, 20221 min read
10 views

Sanitary Emergency extended in Colombia until April 30, 2022
Colombian government by means of Resolution No. 0304/2022 has decided to extend the Sanitary Emergency. This means that products declared...
SVip
Feb 24, 20221 min read
5 views

INVIMA: Suspension of legal terms are extended until February 25, 2022
INVIMA issued Resolution No. 2022500001/2022 by which it modifies former resolutions and suspends legal terms in all on-going processes...
SVip
Feb 23, 20221 min read
17 views

INVIMA: Suspension of legal terms are extended until February 22, 2022
INVIMA modified Resolution No. 2022500000/2022 whereby it decided to suspend legal terms in all on-going processes until February 22,...
SVip
Feb 16, 20221 min read
10 views

INVIMA´s server is unavailable and legal terms have been suspended.
INVIMA issued Resolution No. 2022500000/2022 whereby it decided to suspend legal terms in all on-going processes (requirements, writs,...
SVip
Feb 10, 20221 min read
18 views
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