Mi Regulatorios shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what Mi Regulatorios publishes on its own site (miregulatorios.cl), then compares it with multi-country market access from bioaccess®. It is a practitioner comparison, not a teardown.
What Mi Regulatorios publishes
Mi Regulatorios is a Chilean regulatory practice led by María Inés Silva. Its homepage covers ISP registrations for cosmetics, medical devices, pharmaceuticals and disinfectants, company inscription and warehouse (bodega) resolutions. It is a dossier service, and the site does not present a separate holder product.
Mi Regulatorios vs bioaccess®
| Dimension | Mi Regulatorios | bioaccess® |
|---|---|---|
| Public product | ISP dossiers, company inscription, bodega resolution | Registration, in-country holder, certified translations, tecnovigilancia as holder (import shipments quoted separately) |
| Geography | Chile | Published pricing in Mexico, Colombia, Brazil, Peru and Argentina; other markets quoted case by case |
| Public pricing | None published | Two-part: one-time registration fee per country by class, then an annual holder fee from year 2 (rate card) |
| Holder vs distributor | See the provider’s own terms | Holder under contract (own Colombian entity in Colombia; local partner elsewhere), with defined transfer provisions; the registration is never leverage |
| 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 you already have a Chilean importer and only need the ISP paperwork done, a dossier shop like Mi Regulatorios is the right size.
bioaccess® market access is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and acts as their registration holder under contract (in Colombia through its own Colombian entity; elsewhere with its local partner) across Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. 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). Importer-of-record 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 one local partner is enough? Hire the firm that publishes that job. Several LATAM labels under one holder who is not your distributor? Start at bioaccess® market access, read the LATAM importer of record guide, try the market-access calculator, or request a registration quote.
Competitor facts from the Mi Regulatorios public pages linked above, reviewed for bioaccess® competitive research (Aug–Oct 2026). Claims are theirs. No invented clients, prices or contacts.