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Welcome to
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Welcome to
Latin America
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LatAm Regulatory Hub
Brazil, Mexico, Colombia, Chile, Argentina and Venezuela combined represent the 3rd largest economy in the world with a USD 4.25 trillion GDP
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Holder Service
Holding Service Through MEDISI America you own your product in key LatAm markets (Mexico/Brazil) without opening an office and without losing control of your products and brand.
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COFEPRIS Solutions
Mexico's import Medical Devices market value is of +-5 billion USD
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ANVISA Solutions
Brazil and Mexico represent more than 65% of the Latin America's GDP.
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INVIMA Solutions
Colombia Medical Devices market is accessible and regulations are fairly open to foreigners.
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Local experts. Global reach since 1980
We are MEDISI, we were the first Mexican consultancy company specialized in Medical Devices and now we are the best consolidator for regulation in Latin America and USA.
Our main value proposal is excellence at affordable, ethical rates that can make you our long time partner. We understand your international GMP language and we help you translate it into each local market with timely and business oriented solutions.
LATEST NEWS
COFEPRIS Evolves
COFEPRIS Challenges 2020
Since December 1st, 2018 a historical change in administration that consisted of a new president who is committed to Public Office cleansing of corrupt and unequal practices had a strong impact on the whole country course of operation. Many institutions were eliminated or were audited and restructured. Cofepris was audited and analyzed for permanence or …
ResMed ventilators recall is Class I
FDA today designated a ResMed (NYSE:RMD) recall of certain Stellar non-invasive and invasive ventilators as Class I — the agency’s most serious level. The sound alarm on the ventilators may not work if the device has a failed electronic part, is stored without AC power for more than 36 hours, or powers on automatically when connected …
Finding a non-invasive way to predict effectiveness of cancer therapy.
«Researchers have taken a critical step toward developing a non-invasive nuclear medicine technique that can predict the effectiveness of therapy for cancerous tumors, allowing for personalized, precision treatment.» Read more.
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
«The Food and Drug Administration (FDA, Agency) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21stCentury Cures Act (Cures Act). Although each classification regulation for each …
Researchers produce first laser ultrasound images of humans.
«Engineers have come up with an alternative to conventional ultrasound that doesn’t require contact with the body to see inside a patient. The new laser ultrasound technique leverages an eye- and skin-safe laser system to remotely image the inside of a person.» Read more