Key takeaways. Getting a medical device registered in Latin America is only the first step. To generate meaningful revenue, sponsors need health-technology-assessment (HTA) and payer/reimbursement support alongside device registration across the region. bioaccess® pairs regulatory registration with HTA and reimbursement strategy across our 19 LATAM markets, working with each country's HTA body and regulator — INVIMA (Colombia), ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), ISP (Chile), DIGEMID (Peru), and others already named on the site.
Health Technology Assessment is how public payers decide whether a device is covered by government health systems that cover the majority of the population in most LATAM markets. Without HTA acceptance, a registered device can sit on the shelf. HTA bodies referenced across bioaccess® content include CONITEC (Brazil), IETS (Colombia), CENETEC (Mexico), and ANEFiTS (Argentina).
We combine registration and reimbursement in one engagement: HTA readiness assessment, evidence gap analysis against each body's requirements, value dossier development, budget impact modeling, and payer engagement strategy — aligned from day one with the clinical development plan.
Our 19 LATAM registration markets — including Colombia (INVIMA), Brazil (ANVISA), Mexico (COFEPRIS), Argentina (ANMAT), Chile (ISP), Peru (DIGEMID), Panama (MINSA), Ecuador (ARCSA), El Salvador (DNM/SRS), and Dominican Republic (DIGEMAPS) — are backed by the same in-country entities that handle registration, importation, and post-market obligations. See Market Access and LATAM Importer of Record.
Ideally during clinical development, well before regulatory approval, so clinical endpoints satisfy both regulators and HTA bodies without costly post-approval studies.
Book an HTA strategy session · Related: Market Access · LATAM Importer of Record