ANVISA
Case Study 36: Regulatory Support for Visual Electrodiagnostic Testing System in Mexico and Brazil
The Client is a leading US based manufacturer of visual electrophysiology products used for the diagnosis of retina and optic nerve disease. The products are approved in US as a Class II and III device
May 18, 2021
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ANVISA
Case Study 28 : Registration of Class II Medical Device in Australia, Brazil, China, India, Pakistan and Russia
The Client is a US based medical device company that has registered its class II medical devices in USA, Canada and EU. Client wanted to get approval for its products in international markets
April 14, 2021
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ANVISA
Case Study 38: Regulatory Support for Innovative SmartPen with AI Technology in Brazil.
AI Smartpen Manufacturer seeks GRP’s innovative soltuions for regulatory strategy and Support for complicated product registration for Anvisa-Brazil.
January 14, 2020
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ANVISA
Expansion into Japan, Australia and Brazil for American based Medical Device Company
Company Situation The Client had developed novel devices for multiple applications including for dermatology, cosmetics, plastic surgery and aesthetics. The products already had CE marking
November 7, 2019
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