General information, not legal or regulatory advice. Confirm current INVIMA holder, import, and post-market rules with qualified advisers. We do not invent rates except the locked public LATAM Launch Subscription card (USD 7,500/year all-in) already published on the hub. No unpublished client. Always bioaccess®.
If you searched Colombia INVIMA registration holder IOR, INVIMA titular importer of record, CCAA holder Colombia medical device, you were looking for who holds the Latin American sanitary registration and who can legally import the device. Named market-access competitors on this cluster only: Emergo, Pure Global, Freyr, MedEnvoy, Qserve. We do not invent extra holder brands. Accel already sits on hub CMS 95739; this cluster does not add a ninth Accel slug. This page is not a FIH CRO steal, not leftover-site 42, not insurance 4, not Magical BTK. No PHI.
This is the Colombia holder page. It is market access. It is not a new first-in-human CTA. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Use INVIMA medical device registration checklist for the controlled vs uncontrolled / foreign-holder / CCAA importer checklist. The locked annual card is still USD 7,500/year all-in for the first device family.
This page expands LATAM Registration Holder and IOR (CMS 95739). We do not republish that hub. Distinct slug. Distinct title. Same product: already FDA-cleared (510(k)/PMA) or CE-marked devices, held through bioaccess® in-country entities as registration holder and importer of record. bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO.
The card (do not invent another one)
The locked public card — LATAM Launch Subscription — is USD 7,500 per year per country for the first device family, all-in for the items listed on LATAM Registration Holder and IOR and market-access. Pricing structure effective 2026-06-01. Unlimited models, references, and variants within that family. Additional families quoted on request. We will not invent a new rate on this page. Class-specific published adders already on that hub (Mexico Class III / energy; Brazil Class III/IV + INMETRO pass-through; Class IIb Professional) stay there — do not treat this intercept as a second price list.
Inside the published card, as already stated on the hub: government submission fees; certified/sworn translations (sworn where required, including Brazil and Argentina); in-country titular / RH / IOR / legal representation; post-approval modifications; agency liaison; tecnovigilancia as holder. Published multi-country discounts on that hub: 10% off at 3+ countries; 15% off at 5+. Trial-to-Market Bridge: 20% off for clinical-trial clients. Outside the flat fee (already published, not invented here): Brazil BGMP manufacturing-site audit as a pass-through line; INMETRO / ANATEL / telecom-EMC homologation at vendor cost + 20% G&A; IOR is 20% of CIF per shipment (USD 0 if no import). Submission Guarantee is workmanship (complete dossier submitted, certified Spanish or Portuguese, government fees paid, on the committed schedule) — not a regulator-clock guarantee. Full terms in the proposal.
Holder is not IOR is not EU AR is not FDA US agent
Every LATAM regulator ties a live sanitary registration to an in-country legal entity. That is not a U.S. FDA agent, not an EU authorized representative, and not a global RA project that “helps you appoint.” Registration holder / titular / detentor / BRH / MRH is named on the certificate, owns the registro, runs post-market tecnovigilancia, and can typically authorize or add importers (country rules vary). Importer of record is the entity on the customs entry. In Argentina the holder is the sole importer of record; Peru requires imports through a licensed droguería. A consultancy that helps you appoint a holder is not the holder. A holder that authorizes a distributor to import is often not the customs IOR. Ask which legal entity is on the certificate and which entity is on the import entry. See importer of record for clinical trial devices for the investigational-import workstream — that is a trial object, not this commercial holder SKU.
What INVIMA holder actually is
INVIMA names a Colombian legal entity on the sanitary registration. Foreign manufacturers appoint that titular. CCAA importer rules sit next to the holder, not instead of it. See the live checklist. We will not invent an INVIMA tariff beyond the locked card. MedEnvoy, Pure Global, Freyr, Emergo, and Qserve may appear in the same search; none of them is this slug. Named competitors stay on their own intercepts.
Do not mix trial IOR into commercial holder
Investigational-device import for a protocol is importer of record for clinical trial devices. Commercial IOR for an already-cleared device is this SKU. Avantec / Watershed public FIH copy that names Colombia is historic execution, not a reason to book a new INVIMA FIH from this page. Leftover-site hospital intercepts stay off. Nanochon HOLD. Magical BTK off.
What bioaccess® still owns after you have a holder quote from somewhere else
- Own-entity holder / IOR across the public 19-market footprint named on market-access and the hub — not a brochure that tells you to go hire a local lawyer.
- The registration is never leverage against the manufacturer. Hub language: dedicated local entities for the manufacturer’s benefit, with defined transfer provisions in the agreement.
- Certified/sworn pages inside the card where the country requires them. Do not compare a dossier-only sticker to USD 7,500 all-in.
- Tecnovigilancia as holder after the certificate is live. A one-time filing shop is not that.
- Clinical-to-market is a different stack. FIH ops are ISO 14155. This SKU is already-cleared devices. Do not mix Magical BTK. Do not sell insurance here.
Colombia stays market access on this cluster
Public line, unchanged: INVIMA commercial medical-device registration remains a core bioaccess® service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. Country 2 on this cluster is Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA. The Panama country page still publishes ethics 3–5 weeks vs. Colombia 4–6 weeks and per-patient $12K–$22K vs. $15K–$25K. Always bioaccess®. The founder podcast is Global Trial Accelerators™.
An INVIMA holder / IOR page is registro, CCAA importer rules, and tecnovigilancia — not a new FIH CTA. Do not flip this intercept into leftover-site hospital FIH copy.
Frequently asked questions
Is this a clone of hub CMS 95739?
No. The hub is the eight-firm table and the SKU. This page is INVIMA titular / IOR (registro — not new FIH). Distinct slug. We did not republish 95739.
Do you underwrite clinical-trial liability on this page?
No. Holder / IOR is not a carrier. Insurance intercepts are a different cluster. We do not name HDI as a partner.
Can I use this subscription for a first-in-human investigational device?
No. The public card is for already FDA-cleared or CE-marked devices. Investigational import is importer of record for clinical trial devices. New FIH execution is not recommended in Colombia on the public line above.
Next step
If the search that brought you here was Colombia INVIMA registration holder / IOR, start on the holder line: contact bioaccess® or market-access. Hub: LATAM Registration Holder and IOR. Mexico sibling: COFEPRIS holder / IOR.
Julio G. Martinez-Clark, CEO · bioaccess®