Regulatory Affairs in Colombia

April 21, 2023

The Regulatory Affairs in Colombia are implemented to protect the public when they are consuming products that could affect their health. In this sense, products such as, food, medicines, psychotherapeutics, dietary supplements, cosmetics, alcoholic beverages, medical devices, veterinary applications, among others, will need necessary permits granted by the corresponding authorities to be sold. Hence, in order to sell these kinds of products in Colombia, the company or business will need the respective approval granted by the INVIMA (National Food and Drug Surveillance Institute).

The INVIMA Sanitary Registration is mandatory for all products with a name and brand that will be sold to a consumer in Colombia. This certification document guarantees that a product circulates legally in the country and that it also complies with the technical requirements required by law.

In the case of medical devices in Colombia, it is essential to abide by the regulatory framework stipulated by INVIMA. To comply with such requirements, the first step is to accurately determine the classification of the medical device in question. Such classification is based on the level of risk associated with the equipment and determines the regulatory pathway that your product must follow.

For companies who are selling and making products who will be consumed by the public, most likely certifications and permits will be needed to market said products in Colombia. This documents will be processed before the INVIMA, which is why here at AGT Attorneys we recommend receiving specialized legal advice on Regulatory Affairs by a lawyer when handling such processes.

We are a Colombian law firm, with experience in health and regulatory law in Colombia, that will assist you through all the legal procedures required for your products like medical devices. Contact us by filling the next Contact Form or through our WhatsApp number +57 310 5706331.

Our Expert Lawyers in Sanitary and Regulatory Affairs are specialized in the following areas:

• INVIMA Registration.
• Consultancy on feasibility.
• Preparation of documentation.
• Collection of information.
• Process monitoring.
• Notification of results.
• Sanitary permit portfolios.

On the other hand, there are several steps in the process that can confuse anyone who is not familiar with it. These steps include determining what products can be covered under the same sanitary registration, properly completing the application forms, determining the appropriate payment rate according to the procedure, and understanding how long a record takes to expire. Additionally, it's important to know when a health record must be renewed, as well as other important aspects to consider when beginning a registration request.

At AGT Attorneys, we work with all the industrial sectors to advise them on these regulatory affairs and health issues before the different public entities of the country. The most common products that required regulatory affair certifications and/or permits include medical devices, food products, and cosmetics.

Which are the Regulatory Affairs Certificate for Medical Devices in Colombia?

Colombia's INVIMA medical device classification system is based on the potential health risk related to the use and possible failure of a device. The criteria used involves the duration of contact with the body, how invasive the device is, and local effect vs systemic effect.

In Colombia, medical equipment can be categorized into one of four classes: Class I, Class IIa, Class IIb, and Class III. These classifications indicate levels of risk, with Class I being low risk, Class IIa and IIb representing medium and high risk, respectively, and Class III reserved for very high-risk devices.

Regulatory Affairs classification for medical devices

Class I

• Low risk
• Subject to general manufacturing controls
• No potential harm of disease or injury
• Not destined to protect or maintain life
• Made to prevent the deterioration of human life
• Examples: Surgical instruments, gauze

Class IIA

• Moderate risk
• Subject to special manufacturing controls to demonstrate their safety and efficacy
• Example: Hypodermic needles, suction equipment

Class IIB

• High risk
• Subject to special controls in their design and manufacturing to show safety and efficacy
• Example: Pulmonar ventilator, orthopedic implants

Class III

• Very high risk
• Subject to special controls to protect or maintain life
• Made to prevent the deterioration of life
• Their use represents a potential health risk or injury
• Example: Heart valves, pacemakers
Source: ABC de Dispositivos Médicos (INVIMA)

According to the several requirements and characteristics mentioned above, your medical device will be classified. If you are seeking legal advice regarding the classification applicable for your equipment, do not hesitate to contact us here at AGT Attorneys and book a specialized consultation with one of our experienced lawyers on Regulatory Affairs in Colombia.

Contact us by filling the next Contact Form or through our WhatsApp number +57 310 5706331.

Which are the Regulatory Affairs Requirements to Import Food Products to Colombia?

According to the Article 38 of the Resolution 2674 from 2013, the requirements to import products are:



• Form corresponding to the procedure.
• Certificate of existence and legal representation of the owner and the manufacturer.
• Payment receipt, the amount of which must coincide with that indicated in the INVIMA rate.
• Free sale certificate issued in the country where the food product comes from. It is very important to highlight that if this document is not written in the Spanish language, the official translation of it must be attached.
• Document signed by the producer where the importer is authorized to introduce the food to the country, distribute it, market it; or to be the holder of the sanitary registration of the product in Colombian territory.
• Technical data sheet of the food product according to the format defined by INVIMA.
• Important note: If you are carrying out the procedure through an advisor, you must enter the corresponding power of attorney.

Do you Need to Get Legal Advice over Regulatory Affairs in Colombia?





In AGT Attorneys, we advise and guide companies in all industrial sectors to carry out their regulatory affairs in Colombia. Having our support to carry out your INVIMA health registration, will guarantee you the possibility of legally enabling the circulation of your product in Colombia, which will be presented to consumers with their respective INVIMA health registration number.

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Write to us on our Contact Form, schedule your legal appointment with our lawyers through the following link or contact us at +57 310 5706331. We will be happy to assist you!

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Categories: Invima Registration


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