Reference library
Long-form, statute-verified references for the six regulators that govern most of Latin America's pharmaceutical and device volume — plus the hub that maps how their rules differ.
13 guides available
Pillar guide
The doorway to all six regulator-specific reference guides: language rules, sworn-translation tiers, document-currency windows, and the seven QC gates that hold a LATAM dossier together.
Julio G. Martinez-Clark · Last updated · v1.1.0 · ~18 min read
ANVISA · Brazil
Brazil's language regime by document type: RDC 947/2024 acceptance zones, the RDC 200/2017 sworn carve-out, RDC 751/2022 device Portuguese rules, and the CEP/CONEP clock.
Julio G. Martinez-Clark · Last updated · v2.0.0 · ~34 min read
COFEPRIS · Mexico
The Reglamento de Insumos para la Salud rule set — Arts. 16, 24, 161 fr. III and 179 — plus Tercero Autorizado routing, dual-body ethics review, and Mexican-variant terminology.
Julio G. Martinez-Clark · Last updated · v1.5.0 · ~29 min read
INVIMA · Colombia
Decreto 4725 de 2005 Art. 49, Decreto 677 de 1995 accreditation and the ≤1-year currency rule, Concepto 174/2023 on cumulative apostille, and Colombia's two-day Class I clock.
Julio G. Martinez-Clark · Last updated · v1.3.0 · ~28 min read
ANMAT · Argentina
What the Disposición 6677/2010 repeal changed, the five Disposición 727/2013 translator touchpoints, and why ANMAT is the most Spanish-leaning of the Big 6.
Julio G. Martinez-Clark · Last updated · v1.3.0 · ~29 min read · ICH E6(R3) — first in LATAM
ISP · Chile
The officer-signature translation rule, the Art. 74 item 5 / 29 No. 10 / 78 citation set, Ley 20.850 market access, and the 72-hour serious-ADR window.
Julio G. Martinez-Clark · Last updated · v1.3.0 · ~28 min read · D.Ex. 25/2026 device generalization
DIGEMID · Peru
The Art. 28 two-year currency rule, the INS/DIIS/SUDEC versus DIGEMID/ANM split for trials, and why Document Currency is the seventh QC gate.
Julio G. Martinez-Clark · Last updated · v1.4.0 · ~29 min read · INS/DIGEMID two-agency framework
SRS · El Salvador
The DNM to SRS succession, the RTCA 11.03.59:18 Mutual Recognition launchpad into five neighbouring markets, and the narrowest castellano surface in LATAM.
Julio G. Martinez-Clark · Last updated · v1.4.0 · ~29 min read · SRS succession — Aug 2024
DNFD · Panamá
Ley 419 de 2024 and DE 27's 836 articles, the DE 490 device consultation, the DE 21 de 2026 research reglamento, and where CTA-stage preclinical translation risk actually sits.
Julio G. Martinez-Clark · Last updated · v1.1.0 · ~29 min read · Statute-level English carve-out
ARCSA · Ecuador
Ecuador's resolución-driven language regime: the Module 2 Spanish tightening, the January 2027 device inversion, and LOOETA art. 29 authenticated translations.
Julio G. Martinez-Clark · Last updated · v1.0.0 · ~29 min read · Module 2 tightening — Oct 2025
CONIS · Costa Rica
The three-authority map (CONIS, DRPIRS, CCSS), the Ley 8142 sworn-translation blanket rule, and the version-drift trap after a folio set is cut.
Julio G. Martinez-Clark · Last updated · v1.0.0 · ~30 min read · Sworn folio-set regime
DIGEMAPS · República Dominicana
Decreto 246-06 Art. 39, the intérprete-judicial sworn tier, the traducción fidedigna ethics tier, and the still-unenacted device reglamento.
Julio G. Martinez-Clark · Last updated · v1.1.0 · ~29 min read · CONABIOS Resolución 03-25
DINAVISA · Paraguay
Ley 1119/1997 Art. 11, the INF-DI-01 V01 dual-language items, Resolución 056/2026 and ICH E6(R3), plus the DIEE-versus-DINAVISA routing warning.
Julio G. Martinez-Clark · Last updated · v1.0.0 · ~31 min read · Dual-language IB requirement