SELECTED MARKET-ENTRY CASES
How We Help Global Manufacturers Succeed.
A concise look at how Medisi America turns complex regulatory entry into practical, commercially aligned execution across medical device, diagnostics, imaging, quality, and corporate regulatory functions.
09
case snapshots
05
manufacturer profiles
02
corporate services
01
long-term partner model
CLASS III MARKET ENTRY · EUROPE
European Cardiovascular Device Manufacturer
Entered Mexico with a Class III cardiovascular portfolio through a roadmap, holder services, COFEPRIS coordination, and market-entry strategy.
Medisi became an extension of our regulatory team—not just an approval consultant.
DIAGNOSTICS PORTFOLIO · UNITED STATES
US Allergy Diagnostics Manufacturer
Multiple diagnostic product families were organized under one scalable regulatory strategy with submissions, lifecycle management, and local representation.
Their strategic approach helped us build a scalable regulatory program.
DIAGNOSTIC IMAGING · JAPAN
Japanese Ultrasound Manufacturer
Diagnostic imaging equipment launched with registration strategy, documentation review, local representation, and regulatory coordination.
They understood both regulatory requirements and commercial priorities.
DISTRIBUTION OPERATIONS · MEXICO
Mexican Medical Device Distributor
A Mexican distributor needed a simple way to solve warehousing, regulatory continuity, and tender documentation requirements without adding operational complexity.
They solved our warehouse process simply—and gave us practical solutions for tender requirements.
MULTI-SYSTEM STRATEGY · ISRAEL
Israeli Dental Implant Manufacturer
Multiple implant systems entered Mexico through market-entry planning, registration management, compliance strategy, and lifecycle support.
Their advice balanced compliance with commercial practicality.
LIFECYCLE MANAGEMENT · GLOBAL
Global IVD Manufacturer
A growing diagnostic portfolio stayed compliant through lifecycle regulatory management, change-control strategy, and continuous support.
Their proactive follow-up reduced uncertainty across the process.
CORPORATE SERVICES · MEXICO
Regulatory Function in Mexico City
A global manufacturer gained an operational Regulatory Affairs department with professionals, agency interaction, processes, and lifecycle support.
We gained an experienced regulatory team ready to operate from day one.
QUALITY SYSTEM · TIJUANA
NOM-241 Implementation
A manufacturing site adopted a compliant quality system through documentation, procedures, training, and inspection readiness.
Their approach combined regulatory expertise with practical operational execution.
IMPORT OPERATIONS · MEXICO
Importer of Record Support
A company needed to import medical products into Mexico without building a local import structure. Medisi America simplified the process as importer of record and kept execution compliant.
It was incredible how simple it was to use Medisi as importer of record—and how successful the process became.
GLOBAL CLIENT PARTNERS
International reach that turns regulatory complexity into momentum.
Our work connects manufacturers, regulators, distributors and local experts across the Americas, Europe, Asia-Pacific, Australia and South Africa — giving clients a partner that understands both local requirements and global business ambition.
6
continents connected
15+
markets represented
1
coordinated partner model