MEDISI America
Medisi America is a leading consultancy specializing in medical device regulation and market entry in Latin America and the USA. Since 1980, they have been committed to excellence, providing timely, ethical, and business-oriented solutions to help clients navigate complex regulatory environments and achieve their international goals.
Industries
Nr. of Employees
small (1-50)
MEDISI America
Mexico City, Distrito Federal, Mexico, North America
Products
Regulatory Affairs Consultancy
Consulting services for medical device regulatory affairs in the USA and Latin America, assisting with compliance and registration processes.
Regulatory Affairs Consultancy
Consulting services for medical device regulatory affairs in the USA and Latin America, assisting with compliance and registration processes.
Multi-Country Registrations
Facilitating medical device registrations across multiple countries through regional alliances.
Multi-Country Registrations
Facilitating medical device registrations across multiple countries through regional alliances.
Training
Offering classes in English or Spanish on regulatory and compliance needs for medical devices.
Training
Offering classes in English or Spanish on regulatory and compliance needs for medical devices.
Regulatory Affairs Consultancy
Consulting services for medical device regulatory affairs in the USA and Latin America, assisting with compliance and registration processes.
Regulatory Affairs Consultancy
Consulting services for medical device regulatory affairs in the USA and Latin America, assisting with compliance and registration processes.
Multi-Country Registrations
Facilitating medical device registrations across multiple countries through regional alliances.
Multi-Country Registrations
Facilitating medical device registrations across multiple countries through regional alliances.
Training
Offering classes in English or Spanish on regulatory and compliance needs for medical devices.
Training
Offering classes in English or Spanish on regulatory and compliance needs for medical devices.
Services
Local holder / authorized representative service
Act as the local legal holder or authorized representative to enable product registration and distribution in target Latin American markets without the manufacturer establishing a local office.
COFEPRIS regulatory solutions (Mexico)
Regulatory submission support, dossier preparation, and interactions with Mexico's regulatory authority for medical device registration and approvals.
ANVISA regulatory solutions (Brazil)
Regulatory submission support, dossier preparation, and interactions with Brazil's regulatory authority for medical device registration and approvals.
INVIMA regulatory solutions (Colombia)
Regulatory submission support and market entry assistance for Colombia's regulatory environment.
GMP and quality translation for local compliance
Interpretation and adaptation of international GMP and quality system requirements to the documentation and practices expected by local regulatory authorities.
Regulatory intelligence and local authority monitoring
Monitoring of regulatory authority reorganizations, audit outcomes, and changes in submission criteria to update strategy and expectations for clients.
Local holder / authorized representative service
Act as the local legal holder or authorized representative to enable product registration and distribution in target Latin American markets without the manufacturer establishing a local office.
COFEPRIS regulatory solutions (Mexico)
Regulatory submission support, dossier preparation, and interactions with Mexico's regulatory authority for medical device registration and approvals.
ANVISA regulatory solutions (Brazil)
Regulatory submission support, dossier preparation, and interactions with Brazil's regulatory authority for medical device registration and approvals.
INVIMA regulatory solutions (Colombia)
Regulatory submission support and market entry assistance for Colombia's regulatory environment.
GMP and quality translation for local compliance
Interpretation and adaptation of international GMP and quality system requirements to the documentation and practices expected by local regulatory authorities.
Regulatory intelligence and local authority monitoring
Monitoring of regulatory authority reorganizations, audit outcomes, and changes in submission criteria to update strategy and expectations for clients.
Expertise Areas
- Medical device regulatory affairs
- Latin America market access and registration
- Local representation and legal holder services
- GMP and quality systems translation for local compliance
Key Technologies
- Local market authorization processes (COFEPRIS/ANVISA/INVIMA)
- GMP compliance frameworks
- Regulatory submission documentation and workflows
- Regulatory intelligence and monitoring (policy tracking)