On July 21, 2026, Colombia's Comisión Nacional de Precios de Medicamentos y Dispositivos Médicos (CNPMDM) issued Circular Externa No. 023 of 2026, extending the country's price-control regime from pharmaceuticals into medical devices. The circular establishes general guidelines for monitoring the market behavior of medical devices, subjects selected products to price monitoring, places medicated coronary stents under direct price control, and structures a new Medical Device Price Information Reporting System (SISDIS). For pharma and medtech manufacturers and importers selling into Colombia, it adds a binding reporting and pricing layer on top of INVIMA's sanitary-registration regime.
A Circular Externa is not guidance: under Colombian supervisory practice it is a binding instruction compiled into the Circular Básica Jurídica of the issuing regulator, here the CNPMDM, which sets the precio máximo de venta under Ley 1753/2015 article 72. The full text is published as a direct official document on the MinSalud normativity site (Circular Externa No. 023 de 2026).
What does Circular 023/2026 change for medical device pricing?
It creates the device-side counterpart to the medicines price system. Until now, CNPMDM's direct price-setting operated on pharmaceuticals through Circular 16/2023, with prices tracked in the public SISMED database. Medical devices sat largely outside that pricing loop, regulated mainly through INVIMA's registro sanitario under Decreto 4725/2005. Circular 023/2026 closes that gap by introducing three operative tracks: general market-behavior monitoring for devices, targeted price monitoring on a defined set of products, and direct price control on medicated coronary stents.
Direct price control is the most consequential track. Medicated coronary stents, a high-cost, high-volume implantable, move from a market-priced category into the precio máximo de venta logic already applied to new medicines. The circular also formalizes SISDIS as the device equivalent of SISMED, the reporting channel through which manufacturers and importers must submit price information for supervised products.
Who has to comply, and what must they report?
Every medical-device manufacturer and importer that places monitored products on the Colombian market is pulled in, alongside the pharmaceutical actors already inside the CNPMDM perimeter. Concretely, affected companies must register and keep current their pricing data in SISDIS for the product categories the circular designates, submit the information the reporting system structures (list prices, transaction prices, and reference-price inputs the CNPMDM uses for comparison), and apply the price ceiling fixed for medicated coronary stents once that maximum is set.
The obligation sits on top of, not instead of, INVIMA registration. A device still needs its permiso de comercialización under Decreto 4725/2005 to be lawfully placed on the market; Circular 023/2026 adds the pricing-and-reporting condition on the same product. For multinationals, that means pricing, regulatory affairs and market-access teams in Colombia must now coordinate SISDIS filings alongside their INVIMA renewals, not treat pricing as a downstream commercial decision.
How does this fit Colombia's existing price-control architecture?
Colombia runs a two-gate launch model for new medicines that is unusual outside the region: under Ley 1753/2015 article 72, a new medicine cannot legally launch without an IETS therapeutic-value assessment and a CNPMDM price. IETS (Instituto de Evaluación Tecnológica en Salud) classifies comparative therapeutic value and runs the economic evaluation and budget-impact analysis; CNPMDM then sets the maximum sale price, varying by therapeutic-value category, using the Precio del Medicamento Comparado (PCOM) as the reference. Circular 023/2026 extends the same supervisory logic to devices, with SISDIS as the data backbone.
| Track | Instrument | Information system | Scope after 023/2026 |
|---|---|---|---|
| Medicines price control | Circular 16/2023, Ley 1753/2015 art. 72 | SISMED | Unchanged: new medicines need IETS evaluation + CNPMDM price |
| Device market-behavior monitoring | Circular 023/2026 | SISDIS | New: general monitoring of device market behavior |
| Device targeted price monitoring | Circular 023/2026 | SISDIS | New: selected products under price monitoring |
| Direct price control (devices) | Circular 023/2026 | SISDIS | New: medicated coronary stents under precio máximo de venta |
What should affected companies do now?
First, map the portfolio against the circular's product lists: identify which devices fall under general monitoring, which under targeted price monitoring, and confirm whether any medicated coronary stent SKUs are in scope for direct control. Second, stand up the SISDIS reporting workflow, including the internal sign-off that pricing data submitted to a Colombian supervisor is accurate and current. Third, track the CNPMDM's fixation of the stent price ceiling and adjust list and tender pricing for the Colombian market accordingly. Fourth, brief regulatory affairs, market access and compliance jointly: under Circular 023/2026, pricing on a monitored device is now a regulated condition, not a commercial one.
Continuous, per-jurisdiction real-time monitoring surfaces this kind of change the moment a supervisor publishes it, rather than when a trade newsletter catches up. Obsidian tracks CNPMDM and MinSalud releases as they land.
Take advantage of this real-time watch
For compliance and market-access leads, the practical close is a four-point check: confirm whether your portfolio intersects the device categories Circular 023/2026 designates, verify your SISDIS reporting readiness before the first filing deadline the CNPMDM sets, review medicated coronary stent pricing against the forthcoming ceiling, and brief the team that Colombian device pricing is now a supervised obligation under the same commission that sets medicine prices. Obsidian provides per-jurisdiction regulatory monitoring to keep that picture current.
