Search “consultoría regulatoria INVIMA dispositivos médicos” and DD9 Regulatorio is often the Spanish result that owns the page. That is a dossier and representation shop. It is not a clear “we are your titular holder” product. Sponsors who confuse SERP strength with holder structure end up with an excellent expediente and a distributor still named on the registro. This article states what dd9regulatorio.com actually publishes (retrieved 23 August 2026), without repeating manufacturer names from their site, and then points to the holder subscription from bioaccess®.
What DD9 publishes — and what it does not say
DD9 Regulatorio is a firm specialized exclusively in sanitary regulation of medical devices and IVD before INVIMA. Public metrics on the homepage (theirs): 10+ years; 43 companies accompanied; zero sanctions / zero “negaciones de fondo” on managed filings; 100+ records managed simultaneously; 1,700+ trámites; 350+ sanitary registrations in the firm’s history. They describe a five-stage method: diagnóstico, estrategia, ejecución, monitoreo (they brand a Control Tower), actualización.
Services they list: new registros, renewals, technical and legal modifications, responses to requerimientos, resolution corrections, CCAA certificates, manufacturer changes, importer changes, portfolio expansions, regulatory opinions, estándar semántico, tecnovigilancia, reactivovigilancia. Audiences: international manufacturers needing technical representation; importers and distributors with many records and different titulares; titulares needing maintenance; in-house RA teams; companies evaluating entry.
Read that list again. They work for titulares, importers, and manufacturers. They change importers and manufacturers on existing records. They do not say “actuamos como titular holder.” That is the distinction versus Vexpro’s homepage sentence and versus bioaccess®’s own-entity hold. DD9 can be the right INVIMA dossier counsel. Someone still has to be the named titular and, usually, a CCAA importer. If that someone is the exclusive distributor, the SERP win did not solve the leverage problem.
This page does not repeat client names that appear on DD9’s site. Company-published case anecdotes and success rates stay theirs.
What INVIMA actually requires for a commercial launch
Decreto 4725/2005: Class I and IIa receive registro sanitario automático (expedited issuance, verified post-hoc); Class IIb and III undergo full prior review on the order of ~90 business days. Foreign manufacturers need a Colombian legal face and typically a CCAA-licensed importer on the file. INVIMA allows one titular with several importers. Country page: Colombia INVIMA. IOR split: LATAM IOR.
DD9 vs bioaccess®
| Dimension | DD9 Regulatorio | bioaccess® |
|---|---|---|
| Public product | INVIMA device/IVD dossier + representation | Register + hold already-cleared devices through own entities |
| Holder language | Not a clear “we hold” shop | In-country registration holder / IOR; registration not leverage |
| SERP | Owns Spanish INVIMA-device consultancy queries | Market-access hub + country page + this intercept |
| Geography | Colombia | 19 LATAM markets; gov fees + certified translations included |
| Trial-to-market | Not a published FIH CRO | Colombia FIH CRO since 2010 + commercial registro as a separate live service; 20% Bridge |
The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.
Keep DD9 in mind when the gap is an INVIMA expediente. Hire bioaccess® when the gap is who holds the license in Colombia and in the next four countries, and when that holder must not be the distributor.
If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.
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