Medical disclaimer: This is general information, not medical advice. It does not replace an exam or a conversation with a licensed clinician. Rules and registries change; confirm details with official sources before you decide.
Short answer: medical devices sold and used in Colombia, including implants, need a sanitary registration (registro sanitario) from INVIMA, the national regulator for medicines, devices and food. Before surgery, ask for the device's brand, model and registration number in writing and look it up yourself. After surgery, leave with the implant's identification details, including lot or serial numbers, in your records.
This guide explains what INVIMA does, how to ask for and check the registration, and why those small stickers in your chart can matter years from now.
What INVIMA does
INVIMA, the Instituto Nacional de Vigilancia de Medicamentos y Alimentos, is Colombia's national health products regulator. Among other things, it authorizes medicines and medical devices for sale and use in the country, inspects manufacturers and importers, and monitors safety after products reach the market. Its device safety program is called tecnovigilancia, and it publishes safety alerts (alertas sanitarias) about medicines and devices.
It's one of several checks in a safe surgery plan, and it answers a different question from the others:
| Registry | Question it answers | What it can't tell you |
|---|---|---|
| RETHUS | Is this person a registered health professional, and with what specialty? | How skilled they are, or which devices they use |
| REPS | Is this facility registered, and habilitated for this service at this address? | Which products are on its shelves |
| INVIMA | Is this specific medicine or device authorized in Colombia? | Whether the surgeon or facility is qualified |
For how these fit into Colombia's wider oversight system, including the Superintendencia Nacional de Salud, see Colombian healthcare regulation explained.
What a registro sanitario is, and isn't
A registro sanitario is INVIMA's authorization for a specific product, from a specific holder, to be manufactured, imported, sold or used in Colombia. Medical devices are classified by risk under Colombian rules (Decree 4725 of 2005 sets out classes I, IIa, IIb and III, from lower to higher risk), and higher-risk devices face more scrutiny before registration.
What a registration does tell you:
- The product went through Colombia's approval process and was authorized
- Who holds the registration (titular), and often who manufactures it
- Whether the registration is listed as current, and when it expires
What it doesn't tell you:
- That the specific unit used in your surgery is genuine and stored properly
- That the device is the right choice for your body and goals
- That the same product is approved in your home country, or that a doctor at home will know it well
If you'll want follow-up at home, ask your surgeon whether the device is also approved where you live. A doctor at home will usually find it easier to monitor, image or replace a product they already know.
What to ask for before surgery
You don't need to understand device engineering. You need the identifying details in writing, early enough to check them. Ask your surgeon or coordinator for:
- Manufacturer and brand name of the device
- Model or product line, and the size or type planned (for example, implant volume and profile, or joint component sizes)
- The INVIMA registro sanitario number
- Whether a backup size or alternative product might be used during surgery, and its details too
- What device warranty or replacement policy applies, if any, and who you'd contact
This applies to breast implants, joint replacements, spinal hardware, hernia mesh, fixation plates and screws, and other implanted products. For devices chosen in the operating room, like orthopedic screws in varying sizes, the exact items may only be known afterward, so the after-surgery records matter even more.
Vague answers like “we use the best brand” or “it's all approved” with no name or number, or a reluctance to put the device details in writing, are reasons to pause. So is a price that's much lower than other quotes for the same named product with no clear explanation.
How to look up a registration
INVIMA offers a public online search of sanitary registrations (look for Consulta de Registros Sanitarios on INVIMA's official website). The search lets you look up products by details such as the registration number or the product name. The page is in Spanish, and its layout can change, so start from INVIMA's official site rather than a link someone sends you.
- Get the details in writingBrand, model and registration number, as above.
- Go to INVIMA's official siteFind the public registration search for medical devices. Using a browser's translate feature is fine.
- Search by registration number firstIt's the most specific. If that doesn't return a result, try the product or brand name.
- Compare the result to your quoteCheck the product name, holder, manufacturer and registration status. Note the expiry date if shown.
- Save a dated screenshotKeep it with your quote and consent forms.
- Ask about any mismatch in writingIf the name, manufacturer or status doesn't match, or nothing comes up, ask the surgeon to explain before you pay a deposit.
A missing result isn't proof of wrongdoing; typos, product-name differences and website changes happen. But the burden is on the practice to show you a valid registration, not on you to find it. If you can't confirm it, a doctor at home or a bilingual contact can help you read the result.
Implant records to collect afterward
Implants typically come with labels or stickers carrying identifying codes, and facilities often place these in your medical record. Some manufacturers also provide an implant card for the patient. Before you leave Colombia, ask for copies of:
- The implant labels or stickers from your chart, showing manufacturer, model, size, and lot or serial numbers
- Any implant card or patient information leaflet from the manufacturer
- The operative report listing every implanted device
- Your discharge summary and any warranty registration details
- English translations of key documents, if they're in Spanish
Photograph everything before you fly and store copies in two places, such as your phone and an email to yourself. Give a copy to your doctor at home. Our guides to medical records in Colombia and follow-up at home explain how to request and organize them.
Why it matters years later
Implants can stay in your body for decades. The paperwork is how you, and every doctor after your surgeon, know exactly what's there.
Safety alerts and recalls
Regulators and manufacturers sometimes issue safety alerts or recalls for specific products, models or lots. If you know your exact device and lot number, you can tell whether an alert applies to you. Without it, you and your doctors may be guessing. Check INVIMA's alerts and, if you live elsewhere, your home country's regulator too.
Imaging
Before an MRI, the imaging team needs to know about any implanted metal or device. Exact product details help them decide whether and how to scan you safely. For breast implants, the type of implant can also affect which follow-up imaging your doctor recommends.
Revision or removal
If you ever need a revision, removal or replacement, a surgeon at home will plan more safely knowing the manufacturer, model and size. This is especially important for joint replacements and spinal hardware, where specific tools and compatible parts may be needed.
Keep a one-page “implant summary” in your phone's notes: date of surgery, facility, surgeon, device type, manufacturer, model, size, lot or serial number, and INVIMA registration number. It takes ten minutes and may save weeks of record requests later.
Frequently asked questions
Do medical implants used in Colombia need INVIMA approval?
Medical devices marketed and used in Colombia, including implants, require a registro sanitario from INVIMA. Ask your surgeon for the registration number in writing and check it yourself.
Does an INVIMA registration mean the device is approved in the US or Europe?
No. INVIMA registration is a Colombian authorization. If you want follow-up at home, ask whether the same product is also approved where you live, and confirm with your home country's regulator.
What if I can't find the registration number in INVIMA's search?
Double-check the spelling and try searching by product name, then ask the practice in writing to show you the valid registration. Don't pay a deposit until the mismatch is explained.
What implant records should I take home?
Copies of the implant labels or stickers with manufacturer, model, size and lot or serial numbers, any implant card, the operative report and your discharge summary, plus translations if needed.
Why do lot or serial numbers matter?
Safety alerts and recalls can apply to specific products or lots. Knowing your exact numbers lets you and your doctors tell whether an alert affects you, and helps plan imaging or revision surgery.