Question 1

How much does medical device registration cost in Latin America?

Accepted Answer

The bioaccess® LATAM Launch Subscription (SKU A) is USD 7,500 per year per country for the first device family. Mexico Class III / energy is USD 10,000/year; Brazil Class III/IV is USD 12,000/year + INMETRO pass-through at vendor cost; Class IIb Professional is ~USD 15,000 per each selected country. This calculator shows the subscription fee, not a government-fee invoice.

Question 2

Do multi-country and Trial Bridge discounts stack?

Accepted Answer

No. Multi-country (10% at 3+ countries, 15% at 5+) and the Trial-to-Market Bridge (20% for active bioaccess® clinical-trial clients) can both be eligible. The calculator applies only the larger of the two. Proposal can override.

Question 3

What is included in the annual subscription fee?

Accepted Answer

Government submission fees, sworn/certified translations, in-country titular/RH/IOR/legal representation, and tecnovigilancia as holder.

Question 4

What sits outside the subscription?

Accepted Answer

Brazil BGMP (~$13,500/site), INMETRO pass-through at vendor cost, IOR at 20% of CIF per shipment (USD 0 if no import), and desktop publishing / visual replication (layout-perfect IFUs, scanned PDF reflow, DTP). Certified/sworn translations stay in. Other third-party certifications are billed at vendor cost plus 20% G&A when incurred.

LATAM Launch Calculator | Device registration fee