IzzoMed is a Lima-based company that now publishes an independent Peru registration holder offer for international medical device, IVD, and pharmaceutical manufacturers. The English page is at izzomed.com/peru-registration-holder/ and the Spanish version is at izzomed.com/es/titular-del-registro-en-peru/. The English holder page went live in late September 2026. This article uses only what IzzoMed publishes, then compares it with multi-country market access from bioaccess®.
What IzzoMed publishes
IzzoMed positions itself as a local regulatory representative and registration holder before DIGEMID, Peru’s medicines and devices authority. The holder page lists four parts: local regulatory representation, registration management, registration maintenance (renewals and modifications), and a holder structure that “can remain independent from commercial distribution.” The home page adds importation, storage through authorized healthcare infrastructure, distribution, and commercial development in Peru. IzzoMed also represents specialized oncology equipment in Peru on its own product pages. We found no public price on the site.
The pitch is the right one for Peru. As summarized in the bioaccess® LATAM registration guide, Decreto Supremo N° 001-2024-SA permits an independent Peru registration holder, and imports still flow through a licensed droguería. A titular that is not the exclusive seller lets the manufacturer change or add distributors without losing the registro.
IzzoMed vs bioaccess®
| Dimension | IzzoMed (Peru) | bioaccess® |
|---|---|---|
| Public product | Independent Peru registration holder / MAH, plus import, storage, distribution, and commercial support | Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately) |
| Geography | Peru | Published pricing in Mexico, Colombia, Brazil, Peru and Argentina, including Peru (DIGEMID); other markets quoted case by case |
| Holder vs distributor | Says representation can stay separate from a single distributor; also offers distribution and represents its own product lines | Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage |
| Public pricing | None published | Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card) |
| Bridge from a clinical trial | None published | Same firm can run the LATAM clinical trial and then hold the commercial registration |
Where each one fits
If Peru is the only market and the plan is to build a local commercial channel with one partner, IzzoMed’s published offer covers that job, and it says the right things about keeping the titular separate from the seller.
bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract across Latin America (in Colombia through its own Colombian entity; elsewhere with its local partner). The bioaccess® Peru Holder covers DIGEMID registration through the licensed droguería pathway, and the same holder doctrine applies next to COFEPRIS, ANVISA, INVIMA, and ANMAT. Pricing is two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Import shipments are quoted separately. The registration is held for the manufacturer’s benefit, with defined transfer provisions if you ever change partners or set up your own entity.
One country and a local titular is enough? Hire the shop that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, try the market-access calculator, or request a registration quote.