LATAM Launch / Market Access Essentials rate card — bioaccess®
Annual fees in United States dollars (USD), per country. The first device family is USD 7,500 for low–mid risk in any country. Unlimited models, references, and variants within a family stay on the first-family fee. This is the published rate card for the bioaccess® LATAM Launch Subscription / Market Access Essentials.
First device family (annual, USD / country)
| Risk / country | Fee |
|---|
| Low–mid risk, any country | USD 7,500 |
| Mexico Class III / energy | USD 10,000 |
| Brazil Class III/IV | USD 12,000 + Instituto Nacional de Metrologia, Qualidade e Tecnologia (INMETRO) pass-through |
| Class IIb Professional | ~USD 15,000 |
Unlimited models, references, and variants within a family stay on the first-family fee.
Additional device families (each, annual USD)
| Risk / country | Fee |
|---|
| Low–mid, any country | USD 3,500 |
| Class III / high-risk Mexico | USD 4,500 |
| Class III / high-risk Brazil | USD 5,500 |
Includes
- Government submission fees
- Certified/sworn pages where the authority requires the legal-admin class (Amavita Sciences™ path)
- In-country titular / Registration Holder (RH) / Importer of Record (IOR) / legal representation
- Post-approval modifications
- Agency liaison
- Tecnovigilancia as holder
This page does not publish Amavita Sciences™ list prices.
Exclusions (OUT)
- Brazil Good Manufacturing Practice (BGMP) manufacturing-site audit (~USD 13,500/site)
- INMETRO / Agência Nacional de Telecomunicações (ANATEL) / telecom electromagnetic compatibility (EMC) + radio frequency (RF) homologation — vendor cost + 20% general and administrative (G&A)
- Importer of Record (IOR) physical import — 20% of Cost, Insurance and Freight (CIF) per shipment (USD 0 if no import)
- Desktop publishing (DTP) / visual replication (tables, scanned PDF layout) — client provides or separate quote
- Large-scale Field Safety Corrective Action (FSCA) / recall campaigns — quote when needed
Discounts
- 10% at 3+ countries
- 15% at 5+ countries
- Trial-to-Market Bridge 20% for active bioaccess® clinical-trial clients
If more than one discount could apply, the proposal states which discount applies — they do not auto-stack unless the signed proposal says so.
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