Chapter 1 Columbian INVIMA Administration Information Abstract

1. Administration and Abstract

The regulatory authority supervises medical devices in Colombia is National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de MedicamentosyAlimentos, INVIMA).

It is established by Colombia's Ministry of Health (MoH), the agency's responsibilities include: development and enforcement of regulation, management of medical device market access, post-market supervision and certification.

2. Administrative Regulation

Decree No.582/17

MD: Decree No.4725/2005 and its Amendments

IVD: Decree No.3770/2004 and its Amendments 

3. Risk Level Classification

Colombia's medical device regulatory authority classifies medical devices according to Chapter II of Decree No. 4725/2005, which classifies medical devices into four main categories based on the level of risk and intended use of the device: Class I, Class IIa, Class IIb, and Class III:

IVDs in Colombia are classified into three different categories based on risk level (Class I - low risk; Class II - medium risk; Category III - high risk):

4. Entry Requirements

Both MD and IVD require ISO13485 certificates from the manufacturer to demonstrate the quality system of a legitimate or actual manufacturing facility.

A Colombian registered holder must be appointed as a local representative to liaise with INVIMA.

FSC: The product must hold a free certificate of sale issued by its country of origin or Australia, Europe, Canada, Japan, the United States. The certificate is subject to the Hague certification procedure and the document needs to be translated into Spanish.

5. Registration Language

Spanish.

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Cycle & Official Fee

Registration Cycle

Official Fee

Medical equipment officer fee: $1011 ~ $1021

In vitro diagnostic medical equipment official fee: $700 ~ $1000.

Chapter 3 FAQ

Q: Does INVIMA require applicants to provide proof of product registration history?

A: Yes. Proof of registration history in an INVIMA accredited country (GHTF member) or country of origin is required.

Q: How long is the Colombian Medical Device Registration certificate valid?

A: The certificate is valid for 10 years.

Q: How to deal with that renew the Columbia Medical Device Registration Certificate when close to expiration?

A: The application for renewal needs to be submitted to INVIMA within three months prior to the expiration of the registration certificate.