Question 1

How much does medical device registration cost in Latin America?

Accepted Answer

Under bioaccess®'s Market Access Essentials subscription, registration starts at $7,500/year per country and includes the full registration dossier, distributor introductions, technovigilance, and government submission fees. Class III/high-risk devices are $10,000/yr (Mexico) and $12,000/yr (Brazil); all other countries stay at $7,500/yr.

Question 2

Do you offer bundle discounts for multiple LATAM countries?

Accepted Answer

Yes. The Big 3 (Brazil + Mexico + Colombia) and Andean (Colombia + Peru + Chile) bundles carry 10% discounts. The Full LATAM bundle across all 19 countries carries a 15% discount. Ad-hoc selections of 3+ countries auto-apply 10%, and 5+ countries auto-apply 15%.

Question 3

What is included in the annual subscription fee?

Accepted Answer

Full regulatory registration and annual maintenance, AI-powered market intelligence, distributor identification and introductions, ongoing regulatory monitoring, technovigilance (Mexico and Brazil), translations, all government submission fees, dedicated account management, and the bioaccess® Submission Guarantee.

Question 4

What is not included in the subscription?

Accepted Answer

Pass-through items are billed at vendor cost plus 20% G&A handling: apostille and consular legalization, notarizations, product testing (electrical safety, IEC 60601-series), and Brazil-specific third-party certifications (BGMP ~$13,500/site, INMETRO $4,000–$6,000, ANATEL $3,000–$4,000, INCQS case-by-case). These apply at initial registration, major renewals every 5–7 years, and significant amendments.

Question 5

What does 'device family' mean in the pricing?

Accepted Answer

Each country price includes your first device family (unlimited models and variants within that family). Each additional family is +$3,500/yr per country — or +$4,500/yr in Mexico and +$5,500/yr in Brazil for Class III devices.

LATAM Device Registration Cost Calculator