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 the multi-country subscription 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 | LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately) |
| Geography | Chile | 19 LATAM markets |
| Public pricing | None published | USD 7,500 per year per country for the first device family |
| Holder vs distributor | See the provider’s own terms | Holds through its own in-country entities, with defined transfer provisions; the registration is never leverage |
| Bridge from a clinical trial | None published | Trial-to-Market Bridge: 20% off for bioaccess® clinical-trial clients |
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.
The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared or CE-marked devices and holds them through its own in-country entities across 19 Latin American markets, including COFEPRIS, ANVISA, INVIMA, ANMAT, ISP and DIGEMID. The published card is USD 7,500 per year per country for the first device family, with government submission fees, certified or sworn translations, the in-country titular or holder, and tecnovigilancia inside the fee (importer-of-record shipments are priced separately on the hub). Multi-country discounts are 10% at three or more countries and 15% at five or more. 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 LATAM Launch 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.
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