16 min read
The RFI Anatomy: Six LATAM Rejections Deconstructed
Six real translation-grounds RFIs from INVIMA, ANVISA, COFEPRIS, ANMAT, ISP and DIGEMID: the flagged clause, the error, and the delay each caused.
By Julio G. Martinez-Clark
Field notes
LATAM Regulatory Translation Blog
Regulator-specific notes on translation requirements, review workflows, and submission readiness across Latin America.
Filter by topic
- All
- AI
- ANVISA
- ANVISA IN 290
- ANVISA RDC 945/2024
- Amavita Sciences
- CMC localization
- COFEPRIS
- Certification
- Clinical trials
- Colombia
- Compliance
- DIGEMAPS
- DIGEMID
- Global regulators
- IFU
- INVIMA
- Infrastructure
- LATAM
- LATAM dossier
- LATAM medical devices
- LATAM registration
- MFDS
- MSP Uruguay
- Market
- NMPA
- PMDA
- Preclinical
- Pricing
- Quality
- RFI prevention
- Spanish dossier
- biocompatibility
- clinical trial import
- clinical trials
- cost analysis
- labeling
- localization
- medical device registration
- medical device translation
- medical devices
- preclinical
- radiopharmaceutical
- regulatory affairs
- regulatory reliance
- regulatory translation
- sterilization
- translation rework
12 posts matching your filters
15 min read
The Three Bands of LATAM Regulatory Translation
A cited breakdown of the LATAM regulatory translation market: the $0.05–$0.14 freelance floor, the $0.28–$0.45 Big Four ceiling, and the infrastructure band in between.
By Julio G. Martinez-Clark
11 min read
Sworn vs. Certified Translation: When Each Applies
A document-by-document, country-by-country read on when LATAM and global regulators require a sworn public translator, when a certified statement is enough, and when neither is required at all.
By Julio G. Martinez-Clark
12 min read
Which Regulators Accept English Dossiers?
A module-level map of submission-language rules for devices, pharmaceuticals, and biologics across LATAM and the major global authorities — including where English is accepted and where it never is.
By Julio G. Martinez-Clark
14 min read
Preclinical Translation Requirements Across 9 LATAM Regulators
What ANVISA, COFEPRIS, INVIMA, ANMAT, ARCSA and the rest actually require for Module 4 nonclinical documentation — tier by tier, with the conservative default when guidance is silent.
By Julio G. Martinez-Clark
12 min read
Amendment Cascade: The 12-Country LATAM Math
One protocol amendment × 12 LATAM countries = 900 to 1,700 regulated deliverables. Here's the fan-out math and the parallel architecture that closes it fast.
By Julio G. Martinez-Clark