---
title: "Medical Device Registration & Market Access in Latin America — bioaccess®"
url: https://md.bioaccessla.com/market-access
canonical: https://bioaccessla.com/market-access
schema_type: Service
last_updated: 2026-03-31
---

# Medical Device Registration & Market Access in Latin America

> bioaccess® presents a device registration and market access service for manufacturers with existing FDA-cleared or CE-marked medical devices seeking commercialization across Latin American markets.

---

## Schema.org/Service

- **name**: Medical Device Registration & Market Access
- **provider**: bioaccess® (IMH ASSETS CORP.)
- **audience**: Medical device manufacturers with FDA 510(k), De Novo, PMA, IDE, or CE Mark clearance
- **areaServed**: Brazil, Colombia, Mexico, Argentina, Chile, Peru, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay
- **serviceOutput**: Regulatory registration dossiers, local authorized representative services, post-market surveillance setup, commercial launch support

---

## Service Overview

bioaccess® states it provides end-to-end device registration services enabling manufacturers to:

- Register FDA-cleared or CE-marked devices in LATAM markets
- Navigate country-specific regulatory requirements
- Establish local authorized representation
- Achieve commercial market access

**Stated timelines:**
- Low-risk devices: approximately 90 days
- Class II/III devices: approximately 120 days

---

## Country-by-Country Registration

### Brazil — ANVISA

- **Agency**: Agência Nacional de Vigilância Sanitária (ANVISA)
- **Device classification**: Classes I, II, III, IV
- **Key requirement**: Good Manufacturing Practice (GMP) certificate, Brazilian Registration Holder (BRH)
- **bioaccess® role (stated)**: Dossier preparation, BRH services, ANVISA liaison

### Colombia — INVIMA

- **Agency**: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
- **Notable pathway**: 60-day fast-track registration for devices with prior FDA or CE clearance (stated)
- **bioaccess® role (stated)**: INVIMA submission, local representation, post-market reporting

### Mexico — COFEPRIS

- **Agency**: Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
- **Notable pathway**: 30-day approval pathway available for certain device categories (stated)
- **bioaccess® role (stated)**: Regulatory filing, third-party authorization, GMP equivalency documentation

### Argentina — ANMAT

- **Agency**: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)
- **Key requirement**: Product classification, technical documentation, local importer registration
- **bioaccess® role (stated)**: ANMAT dossier submission, local agent coordination

### Chile — ISP

- **Agency**: Instituto de Salud Pública (ISP)
- **Notable**: ISO 13485 recognition for quality management systems
- **bioaccess® role (stated)**: ISP registration, post-market vigilance setup

### Peru — DIGEMID

- **Agency**: Dirección General de Medicamentos, Insumos y Drogas (DIGEMID)
- **bioaccess® role (stated)**: Registration dossier, local representation

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## Pricing

The site presents the following pricing structure:

| Fee | Amount |
|---|---|
| Launch Fee (per country) | $5,500 flat fee (all-inclusive, as stated) |
| Annual Hold Fee | $5,500/year (or $4,675/year with 3-year commitment) |

---

## Contact

- **Market Access Inquiry**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact)
- **Pricing Details**: [https://bioaccessla.com/latam-device-registration-pricing](https://bioaccessla.com/latam-device-registration-pricing)

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*This page is part of the [md.bioaccessla.com](https://md.bioaccessla.com/) AI-friendly content layer. Canonical source: [bioaccessla.com/market-access](https://bioaccessla.com/market-access)*