一.Colombian Medical Device Regulatory Authority
The regulatory body responsible for overseeing medical devices in Colombia is the National Institute for the Surveillance of Medicines and Foods (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, INVIMA). Established by the Colombian Ministry of Health (MoH), the agency’s primary responsibilities include: rulemaking and enforcement, management of market access for medical devices, and post-market surveillance and inspections.
Regulatory Authority Website: https://www.invima.gov.co/
Database link: https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/base-de-datos-ddmyot
二.Regulatory Framework
DECREE 582 OF 2017
MD: DECREE NO. 4725 OF 2005
IVD: DECREE NO. 3770 OF 2004
三.Risk Classification of Medical Devices and IVD Products
In accordance with Chapter II of Decree No. 4725/2005, Colombia classifies medical devices into four risk classes based on their risk level and intended use: Class I (low risk), Class IIa (low-to-moderate risk), Class IIb (moderate-to-high risk), and Class III (high risk).
In vitro diagnostic (IVD) devices are classified separately, from low to high risk, as Class I, Class II, and Class III.
四.Essential Requirements for Market Access
① Both MDs and IVDs require manufacturers to provide an ISO 13485 certificate to demonstrate the quality system of the actual manufacturing facility;
② A Colombian-registered authorized representative must be appointed to serve as the local representative responsible for liaising with INVIMA;
③ A Free Sale Certificate (FSC) issued by the country of origin or by Australia, the European Union, Canada, Japan, or the United States must be provided. This certificate must be Hague-certified, and all documents must be translated into Spanish.
五.Registration Language
Spanish
六.Registration Process, Timeline, and Official Fees
- Registration Process
(1) Confirm Product Classification
Reference Standard: RISK CLASSIFICATION OF MEDICAL DEVICES, B.E. 2562 (2019) (Medical Device Risk Classification Standard, corresponding to the 2019 edition).
(2) Selection of Registration Pathway
(3) Preparation of Registration Documents
Documents are divided into three categories:
Quality Management System Documentation: ISO 13485
Documents Requiring Notarization: POA (Power of Attorney), FSC (Free Sale Certificate)
Other Registration Documents
(4) Preparation of Registration Application Materials
(5) Submission of Registration Application
(6) Official Review (Conducted via Designated Pathways)
The regulatory authority initiates a differentiated review process based on the product’s risk class:
Path A: Class I / Class IIa Product Review
Proceeds through the low-risk review channel, with review and approval completed according to the corresponding regulatory process.
Path B: Class IIb / Class III Product Review
Proceeds through the dedicated high-risk review channel, with a review and approval cycle of 4–6 months.
(7) Obtaining the Certificate
(8) Certificate Validity Period and Renewal Requirements
Certificate Validity Period: 10 years
Renewal Application: A renewal application must be submitted to INVIMA (National Institute for Food and Medicines) within 3 months prior to the expiration of the registration certificate.
- Official Review Period
- Official Fees
Class I - Class IIa: USD 1,298
Class IIb - Class III: USD 1,147
七.Frequently Asked Questions
What should I do if my Colombian medical device registration certificate is about to expire and I want to renew it?
How long is the validity period of a Colombian medical device registration certificate?
Does INVIMA require applicants to provide proof of the product’s registration history?
