SPI Americas shows up when manufacturers search for a Latin American registration holder or sanitary-registration partner. This article uses only what SPI Americas publishes on its own site (spiamericas.com/asuntos-regulatorios), then compares it with the multi-country subscription from bioaccess®. It is a practitioner comparison, not a teardown.
What SPI Americas publishes
SPI Americas is a Colombia-based firm with regulatory, IP and corporate practices. Its regulatory affairs page sells "hosting" ("parqueadero regulatorio"), where SPI becomes the party responsible before the authority, plus INVIMA dossiers, CCAA, semantic standard and tecnovigilancia. It works across several Latin American countries from Colombia, and the INVIMA work is the deepest.
SPI Americas vs bioaccess®
| Dimension | SPI Americas | bioaccess® |
|---|---|---|
| Public product | Regulatory hosting ("parqueadero regulatorio") + INVIMA dossiers, CCAA, tecnovigilancia | LATAM Launch Subscription: registration, in-country holder, certified translations, government fees, tecnovigilancia (import shipments quoted separately) |
| Geography | Colombia-led, multi-country Latin America | 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 Colombia is the anchor market and you also want IP or corporate counsel from the same firm, SPI Americas is a sensible pick.
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 SPI Americas 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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