Why it matters before you sign
In Colombia, biomedical equipment cannot be legally imported or sold without the sanitary authorization issued by INVIMA, the national food and drug regulator. For a buyer, that authorization is the first filter: if it does not exist, has expired or does not cover the model being quoted, the rest of the technical evaluation is moot.
This guide explains what a sanitary registration is, how long it lasts and how to check it yourself in INVIMA's public database. It cites the regulation at every step so your procurement or clinical engineering team can verify it.
This guide is for buyers and does not replace regulatory advice. Regulations reviewed in September 2026; always confirm current information with INVIMA.
1. What a sanitary registration is
The general framework is Decree 4725 of 2005 of the Ministry of Social Protection, amended by Decree 582 of 2017. Article 2 defines the sanitary registration as the public document issued by INVIMA, after verifying technical, legal and sanitary requirements, that authorizes a person or company to produce, market, import, export, package, process, sell and/or store a medical device.
Two practical consequences:
- The registration has a holder. It is an authorization in a company's name, not a property of the equipment. Check who the holder is and who the importer is.
- One registration can cover several models. Article 28 allows devices from the same holder and manufacturer with minor differences, or that work together as a system, to be covered by a single registration. So it is not enough for the brand to "have INVIMA": the model or reference you are quoted must be listed.
2. Who needs it
Under Article 16 of Decree 4725, medical devices and biomedical equipment require a sanitary registration to be produced, imported, exported, stored, sold and marketed.
Some equipment the decree calls "controlled technology" (including used or refurbished equipment) is covered by a marketing permit instead of a sanitary registration. INVIMA issues it too, and you verify it the same way.
3. How long it lasts and how it is renewed
- Validity: 10 years from issue (Article 31 of Decree 4725; INVIMA confirms it in its FAQ).
- Renewal: it keeps the same number followed by the letter R and a sequence number (R1, R2…). The renewal must be filed three months before expiry; if filed late, it is processed as a new application (Article 32).
A number ending in R means the registration has been renewed at least once. If the expiry date falls within your contract period, ask the supplier whether the renewal has already been filed.
4. How to verify it in INVIMA's database
- Ask the supplier, in writing, for the sanitary registration or marketing permit number of each quoted model.
- Go to INVIMA's public search: invima.gov.co/consulta-registros-sanitarios and use Consulta avanzada (advanced search).
- Search by registration number or product name.
- Compare the quote against the registration's status and validity, its holder and importer, the manufacturer and the covered models or references: the quoted model must be listed.
If anything does not match, ask for a written explanation before moving forward.
5. What the equipment must come with
On the label. Article 54 requires the label to show, at a minimum and in Spanish: product name, lot or serial number, expiry date where applicable, the sanitary registration or marketing permit number, and the manufacturer and/or importer with their address. For imported devices, Article 55 also requires the name and address of the importer or the manufacturer's authorized representative.
The manuals. For biomedical equipment, the holder or importer must declare to INVIMA that it has operating and maintenance manuals in Spanish and commit to delivering them when the equipment is purchased (Article 18, item h). Require them at delivery.
6. After the purchase: traceability and technovigilance
- Traceability. Whoever imports or sells medical devices must keep, at a minimum, the trade name, model, serial or lot number, purchase date, shipping date and the identity of the first customer (Article 63). Record the same data in your inventory.
- Technovigilance. Resolution 4816 of 2008 regulates Colombia's National Technovigilance Program (the monitoring of adverse events involving medical devices). Healthcare providers must run an institutional technovigilance program with a designated professional (Articles 9 and 10). Serious adverse events and incidents must be reported to INVIMA within 72 hours (Article 15); non-serious ones, in consolidated quarterly reports (Article 16). Add every new piece of equipment to that program from day one.
Summary for procurement
| Check | Where | Regulation |
|---|---|---|
| Registration or permit number per model | Supplier's quote | Decree 4725, Art. 16 |
| Validity and covered model | INVIMA public database | Arts. 28 and 31 |
| Holder, importer and manufacturer | INVIMA public database | Art. 2 |
| Spanish label with registration number | Equipment on arrival | Arts. 54 and 55 |
| Operating and maintenance manuals in Spanish | Equipment delivery | Art. 18, item h |
| Inclusion in the technovigilance program | Your institution | Res. 4816 of 2008 |
Next, see the INVIMA checklist before buying medical equipment. If you need help checking a device's documentation before buying it, talk to an I-ME advisor.
Sources
- Decree 4725 of 2005, Ministry of Social Protection — text on INVIMA's site.
- Decree 582 of 2017 (amends Articles 21 and 30 of Decree 4725) — text on INVIMA's site.
- Resolution 4816 of 2008, National Technovigilance Program — INVIMA compilation.
- INVIMA, medical devices FAQ.
- INVIMA, sanitary registration search.