What Is INVIMA? Functions, Products It Regulates, and How It Operates (2026)

INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, the National Institute for Food and Drug Surveillance) is Colombia’s health authority, in charge of overseeing and controlling the quality, safety, and efficacy of products for human use or consumption. This includes food, medications, cosmetics, medical devices, dietary supplements, cleaning products, household pesticides, alcoholic beverages, in vitro diagnostic reagents, and others.

Any company that manufactures, imports, or sells these products in Colombia needs a sanitary authorization from INVIMA. Without that authorization, selling the product constitutes a health-regulation violation.

What is INVIMA and what does the acronym stand for?

INVIMA is the acronym for the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (National Institute for Food and Drug Surveillance). It is a national public institution, with legal personality, administrative autonomy, and independent assets, attached to the Ministry of Health and Social Protection.

It was created by Ley 100 of 1993 as part of the restructuring of Colombia’s health system. Its main function is to protect and promote public health through the management of the risk associated with the consumption and use of the products it regulates.

Ministry it belongs to

INVIMA is attached to the Ministry of Health and Social Protection. This means it operates under the Ministry’s direction and policies, but has technical and administrative autonomy to carry out its inspection, surveillance, and control functions.

INVIMA’s functions: inspection, surveillance, and control

Decreto 2078 of 2012 sets out 20 functions for INVIMA. These fall into three broad areas of action:

Inspection

INVIMA conducts inspection visits to establishments where regulated products are manufactured, stored, distributed, or sold. This includes production plants, warehouses, commercial establishments, and points of entry into the country (ports, airports, and border crossings). The inspections verify that operating conditions comply with the current health regulations.

Surveillance

INVIMA runs specialized surveillance systems by product type. Pharmacovigilance monitors the safety of medications after their authorization, technovigilance does the same for medical devices and biomedical equipment, reagent vigilance (reactivovigilancia) monitors in vitro diagnostic reagents, and food health surveillance detects and manages alerts related to food safety. These systems let INVIMA take preventive and corrective measures when risks are identified.

Control

When INVIMA detects non-compliance, it can apply health measures and penalties. These include fines, seizure of products, temporary or permanent closure of establishments, suspension or cancellation of sanitary authorizations, and border control measures to block the entry of products that do not meet the regulations. In serious cases, violations can give rise to criminal liability.

What products does INVIMA regulate?

INVIMA regulates a wide range of products organized under four technical directorates. Each directorate specializes in a group of products with specific regulations and processes. Below is each group with its definition and the type of authorization it requires.

Directorate of Medications and Biological Products

• Chemically synthesized and biological medications: require a sanitary registration. Chemically synthesized medications make up the majority of conventional drugs; biologicals include vaccines, blood derivatives, and insulins.
• Homeopathic medications: require a sanitary registration. They are pharmaceutical preparations obtained through homeopathic techniques, following the rules described in the official pharmacopoeias accepted in the country, with the aim of preventing, relieving, curing, treating, or rehabilitating a medical condition.
• Dietary supplements: require a sanitary registration. They are products whose purpose is to add to the normal diet and serve as a concentrated source of nutrients and other substances with a physiological or nutritional effect.
• Phytotherapeutic products: require a sanitary registration. They are products based on medicinal plants, classified by use and origin into different categories (PFM, PFT, PFTI, among others). Their composition cannot contain isolated, chemically defined active ingredients.

Directorate of Food and Beverages

• Food: requires a sanitary registration (high risk), a sanitary permit (medium risk), or a sanitary notification (low risk), according to the classification in Resolución 719 of 2015. These are natural or artificial products that, when ingested, provide the body with the nutrients and energy needed for biological processes; the category includes non-alcoholic beverages. Food procedures are handled through the InvimAgil platform.
• Alcoholic beverages: require a sanitary registration. They are products fit for human consumption that contain an alcoholic strength of no less than 2.5 degrees and that carry no therapeutic claims.

Directorate of Medical Devices and Other Technologies

• Medical devices: require a sanitary registration and are classified into four classes (I, IIA, IIB, III) according to their risk level. They are instruments, apparatus, machines, software, or similar articles intended for the prevention, diagnosis, treatment, or relief of a disease or injury in humans.
• Controlled biomedical equipment: requires a marketing permit. These are medical devices subject to special health control because of their risk level and their technology.
• In vitro diagnostic reagents: require a sanitary registration and are classified into three categories (I, II, III). They are products used to analyze samples of human origin outside the body, for diagnostic purposes.

Directorate of Cosmetics, Cleaning, Pesticides, and Household Hygiene Products

• Cosmetics: require a Mandatory Sanitary Notification (NSO), a type of authorization different from a sanitary registration. They are substances or formulations applied to the surface parts of the body, the teeth, or the oral mucosa to clean them, perfume them, protect them, or improve their appearance, and they cannot make therapeutic claims.
• Household cleaning products: require an NSO. They are formulations whose main function is to remove dirt, disinfect, freshen the air, and care for utensils, objects, clothing, or areas that will later be in contact with people.
• Absorbent and personal-hygiene products: require an NSO. They include sanitary pads, disposable diapers, tampons, and liners, provided they do not claim cosmetic properties or therapeutic indications.
• Household pesticides: require a sanitary registration. They are products applied in the environment to combat organisms capable of causing harm to people, animals, plants, or objects.

Types of sanitary authorization

The sanitary authorization INVIMA issues can be of different types depending on the product category. Each type has its own process and validity.

Sanitary registration

This is the type of authorization that applies to products requiring detailed technical evaluation before they are sold: medications (chemically synthesized, biological, and homeopathic), dietary supplements, phytotherapeutics, medical devices, in vitro diagnostic reagents, alcoholic beverages, pesticides, and high-risk food.

Marketing permit for controlled-technology biomedical equipment.

It is the type of authorization that empowers a natural or legal person to produce, market, import, export, assemble, process, dispense, or sell a piece of controlled biomedical equipment.

Sanitary permit

It applies exclusively to food classified as medium risk.

Sanitary notification

It applies exclusively to food classified as low risk.

Mandatory sanitary notification (NSO)

It applies to cosmetics, cleaning products, and absorbent personal-hygiene products. It is a sworn statement before INVIMA in which the holder declares that the product meets quality standards in its manufacture.

For a detailed guide on how to obtain each type of authorization, see our article INVIMA Sanitary Registration: Complete Guide for Colombia.

Validity by product category

The validity of the sanitary authorization varies by category. The renewal application must be filed at least 3 months before expiration.

Type of product	Validity	Reference regulation
Medications	Indefinite	Dec. 334 of 2022
Homeopathic products	Indefinite	Dec. 1737 of 2005
Dietary supplements	10 years	Dec. 3249 of 2006
Phytotherapeutics	10 years	Dec. 1156 of 2018
Medical devices and biomedical equipment (all classes)	10 years	Dec. 4725 of 2005
In vitro diagnostic reagents, cat. I and II	10 years	Dec. 3770 of 2004
In vitro diagnostic reagents, cat. III	5 years	Dec. 3770 of 2004
High-risk food (sanitary registration)	5 years	Res. 2674 of 2013
Medium-risk food (sanitary permit)	7 years	Res. 2674 of 2013
Low-risk food (sanitary notification)	10 years	Res. 2674 of 2013
Cosmetics and household hygiene products (NSO)	7 years	Dec. 833 of 2018 CAN
Household pesticides	10 years	Dec. 1843 of 1991
Alcoholic beverages	10 years	Dec. 1686 of 2012

INVIMA’s technology platforms

• Oficina Virtual (INVIMA’s online portal, app.invima.gov.co): the platform for the digital handling of most procedures. It currently covers medications, medical devices, dietary supplements, phytotherapeutics, cosmetics, cleaning products, and other regulated products.
• InvimAgil (mesagil.invima.gov.co): the platform currently enabled for food and non-alcoholic beverages. On this platform the user fills in and uploads all the required information directly. The authorization is issued immediately upon completing the process. INVIMA is progressively migrating the remaining products to this platform: cosmetics and medications have already begun the transition.
• Sanitary registration lookup: anyone can check the status of a sanitary authorization at invima.gov.co/consulta-registros-sanitarios. The system offers three options: basic search, specialized search, and InvimAgil search.

The scope of each platform can change as the migration of procedures advances. Before starting an application, check at invima.gov.co which platform applies to your product.

Note: the VUCE (Ventanilla Única de Comercio Exterior, Colombia’s single window for foreign trade) is not an INVIMA platform. It is used for import licenses and INVIMA approvals.

How to operate before INVIMA: practical recommendations

When to seek regulatory advice

Colombian health regulation varies significantly between product categories. An error in the initial classification can delay a procedure by months or lead to its rejection. Companies planning to launch a regulated product in Colombia, import products from other countries, renew or modify existing authorizations, or resolve requirements from INVIMA benefit from having specialized regulatory advice from the start of the process.

Common mistakes that delay procedures

Based on the experience of SPI Américas’ regulatory team, the most frequent mistakes are:

• Misclassifying the product under a regulation that does not apply to it.
• Incomplete legal documents or errors in their legalization.
• Incorrect technical documents or ones that do not match the type of procedure.
• Incomplete applications that do not meet all the platform’s requirements.
• Lack of consistency between the documents submitted.
• Failing to respond to requests for additional information within the established deadline.

Next step

If your company needs to obtain, renew, or modify a sanitary authorization before INVIMA, SPI Américas’ regulatory affairs team supports you at every stage. Contact us for specialized advice on defining the best regulatory path for your product. Write to us at [email protected] or visit spiamericas.com.

Last updated: June 2026