Most US and EU sponsors enter LATAM sequentially: Brazil first (largest market), then Mexico, then the Andean tier. This is leaving 12–18 months on the table.
ANVISA (RDC 751/2022) and COFEPRIS (NOM-241) accept ISO 13485 audit reports — which means the bulk of your QMS evidence can be reused. The country-specific work is around technical documentation, labelling, and local sponsor relationships.
Our PT/ES dual-track methodology compresses the timeline by 40%. The key is parallel-authoring technical files with a shared evidence backbone, then forking for country-specific labelling and clinical evidence summaries.