What INVIMA is
INVIMA is the Instituto Nacional de Vigilancia de Medicamentos y Alimentos. According to the agency's own 2025 user guide, it was created under Ley 100 de 1993, had its structure set by Decreto 1290 de 1994 and began operating in 1995. Ley 1122 de 2007 later strengthened its inspection and control role (INVIMA, 2025).
INVIMA's website groups the products it oversees into four families: foods and beverages, medicines, cosmetics and cleaning products, and medical devices (INVIMA, accessed 2026). English-language articles often call it "Colombia's FDA." That shorthand is useful as long as you remember it is about products, not about the places and people providing your care.
Medical devices and implants
For surgical patients, the medical-device side is the most relevant. INVIMA's guide says its Directorate of Medical Devices and Other Technologies is responsible for inspection, surveillance and control of medical devices. It processes sanitary registrations, marketing permits, certifications and notifications under Decreto 4725 de 2005 (INVIMA, 2025).
In practice, if your operation involves something that stays in your body, such as a breast implant, hernia mesh, orthopedic hardware, a dental implant or a stent, that product should be traceable to a manufacturer and a registration. Ask your surgeon before the operation:
- Which brand and model will be used?
- Will I get the product sticker, lot number or implant card afterwards?
- What is the product's INVIMA registration number?
Our guide to implant and device records to take home explains why this paperwork matters years later, for imaging, recalls and revision surgery.
How to look up a registration
INVIMA's public consultation page offers three tools: a basic search, an advanced search and a service called InvimÁgil. The agency says they let the public check the validity and status of the sanitary registrations it has issued (INVIMA, accessed 2026). Its 2025 guide also covers a newer product-consultation tool that shows whether a product needs a registration at all.
Get the details from your surgeon
Ask for the brand, product name and registration number in writing. A photo of the box or sticker is ideal.
Search INVIMA's consultation tool
Start with the registration number if you have it, or with the product or brand name. The interface is in Spanish, and a browser translation feature works well enough.
Read the status
Check that the registration is listed as current, and that the holder and product description match what you were told.
Ask about anything that doesn't match
A mismatch may have an innocent explanation, such as a distributor's name or a product family listing. Ask the surgeon to explain it before surgery, not afterwards.
Where INVIMA's role stops
Patients often lump all of Colombia's safeguards together. They are run by different bodies and answer different questions.
| Layer | What it covers | Where to check |
|---|---|---|
| Product registration | Medicines, devices, implants, cosmetics, foods | INVIMA's registration lookup |
| Provider authorization (habilitación) | Whether a clinic or hospital is authorized to offer a service | The Ministry of Health's provider registry |
| Professional registration | Whether a clinician is registered to practice | National professional registry (see our ReTHUS and REPS checklist) |
| International accreditation | Whether an organization meets an accreditor's standards | The accreditor's own database, e.g. JCI |
For provider authorization, regional health secretariats also play a role. In a 2017 announcement, Antioquia's health secretariat sent patients to the Ministry of Health's registry of authorized providers. It said authorized clinics in the department are inspected every year, and that serious deficiencies can lead to temporary or total closure (Gobernación de Antioquia, 2017). That is a facility regime, separate from INVIMA's product oversight.
For accreditation, JCI says organizations must be reaccredited every three years (JCI, accessed 2026). Our guide on verifying current JCI status covers that check.
INVIMA and the medicines you take
The same registration system shapes how medicines are sold. According to the Pan American Health Organization, antibiotics are classed as prescription-only when they are registered under Decreto 677 de 1995, and pharmacies must ask for a prescription for products labeled venta bajo receta médica (PAHO, 2020). PAHO also reports that enforcement at the pharmacy counter has been uneven. Our pharmacy guide for medical tourists turns that into practical advice for recovery.
Colombian registration and your home country
A product registered with INVIMA is authorized for the Colombian market. That doesn't tell you whether the same product, or the same model, is approved where you live. The difference rarely matters on the day of surgery, but it can matter later. A surgeon at home may be less familiar with an implant that isn't sold in your country, replacement parts may be harder to find, and recall notices may reach you through different channels.
So when you ask about an implant, ask two extra questions: "Is this model also approved in my home country?" and "If it needs replacing, can that be done with the same system there?" If the answer is no, that isn't automatically a reason to refuse. It's a reason to record the manufacturer, model and lot number carefully, and to tell your home clinician.
A worked example (illustrative)
Illustrative only, with no real product or clinic named. A patient planning hernia repair asks which mesh will be used. The surgeon names a manufacturer and product line and gives an INVIMA registration number. The patient searches INVIMA's consultation tool and finds the registration listed as current, under the distributor's name rather than the manufacturer's. The patient asks about it, and the surgeon explains that the distributor holds the Colombian registration. After surgery, the patient leaves with the product sticker and lot number in the discharge papers, and gives copies to their home doctor. Nothing went wrong, but if questions ever come up about that product, the patient can answer them in minutes.
Products used outside hospitals
Not every product used on medical travelers is used in an operating room. Treatments in aesthetic clinics, wound-care products in recovery houses, and items bought in pharmacies all fall within the product families INVIMA oversees. The same habit applies: ask what the product is, ask whether it is registered, and keep the packaging or label until treatment is over. Be especially careful with anything injected, and with any product offered at a price that seems too good to be true. The U.S. State Department warns that counterfeit medicines are common in Colombia (U.S. State Department, 2025).
A registration is not an endorsement
A valid INVIMA registration means a product is authorized for the Colombian market. It doesn't mean it was the right product for your operation, that it was stored or handled correctly, or that the person implanting it was qualified. Those questions belong to your surgeon and the facility.
Questions this explainer should help you ask
- "Which implant or device, by brand and model, will you use, and what is its INVIMA registration?"
- "Will I leave with the product sticker or implant card?"
- "Is the facility where you operate authorized for this procedure in the Ministry's registry?"
- "Is that facility accredited by an international body, and can I see it in that body's database?"
The Takeaway
Think of INVIMA as the product layer. It can confirm that what goes into your body is registered. It can't tell you whether the clinic, the surgeon or the recovery plan is sound, so check those separately.
Frequently asked questions
Does INVIMA inspect or license hospitals?
INVIMA's core job is oversight of products such as medicines, devices, foods and cosmetics. Whether a clinic is authorized to offer a service is checked through the Ministry of Health's provider registry, with regional health secretariats involved in inspections.
How can I check that my breast implant or mesh is registered in Colombia?
Ask your surgeon for the brand, model and INVIMA registration number. Then search INVIMA's public consultation tool, which shows whether a registration is valid and current.
Is INVIMA the same as the FDA?
It plays a similar role for products in Colombia, but it is a separate national regulator. A product can be registered in one country and not the other, so check the registration that applies where the product is used.
Is the INVIMA website available in English?
The consultation tools are in Spanish. A browser's translation feature is usually enough to read a registration's status, and your surgeon's office can help explain an entry.
If a product has an INVIMA registration, is my surgery safe?
Not by itself. Registration covers the product's market authorization. Surgical safety also depends on the surgeon, the facility, anesthesia and aftercare.