Posts tagged medical device registration
Mandala International and bioccess.™ Sign Cooperation Agreement for Medical Device Regulatory and Market Access Consulting Services in Brazil, Colombia, and Mexico

MANDALA International ("MANDALA"), a leading regulatory consulting company in France, and bioaccess.™ announce a cooperation agreement to work together to help each other's clients with their regulatory and market access needs in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America. Under this cooperation agreement between MANDALA and bioaccess.™, now foreign manufacturers of medical technologies will be able to cost-effectively and timely obtain market clearance for their products, have a well thought out market access plan, and find reliable local distributors so that they can achieve meaningful sales and have long-term growth in Brazil, Colombia, and Mexico —the top three medical device markets in Latin America.

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bioaccess.™ Helps ClarVista Medical (acquired by Alcon) Gain Approval in Colombia to Commercialize its HARMONI® Modular IOL – a Novel IOL Used to Restore Vision after Cataract Surgery

ClarVista Medical, Inc. ("ClarVista"), a privately-held ophthalmic device company —acquired by Alcon in 2017— developer of the HARMONI Modular IOL System, a novel intraocular lens (IOL) used to restore vision after cataract surgery, obtained regulatory approval at Colombia's INVIMA to commercialize its HARMONI Modular IOL. bioaccess.™ led the registration process and became ClarVista's legal representative in Colombia. 

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