STD Med receives second Certificate of Good Practices for Manufacturing of Class III Medical Devices


STD Med, Inc. is pleased to announce that it has received a second Certificate of Good Practices for Manufacturing of Class III Medical Devices from ANVISA, the Brazilian National Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria –ANVISA). All medical devices must be registered with ANVISA before being sold in Brazil. The Certificate of Good Practices was granted to STD Med after an intensive audit by the Brazilian agency. The audit process is a comprehensive inspection of policies, procedures and facilities and can often take a number of years to complete. It is one of the primary hurdles for new medical device product registration in Brazil.

SyncMedical LLC, a subsidiary of STD Med, Inc., worked in partnership with Sinnergy Medical, one of its Brazilian distributors, to achieve approval in less than four months. “SyncMedical is uniquely positioned to further assist in establishing emerging new technologies in Brazil,” said Steven Tallarida , President of both STD Med, Inc. and SyncMedical LLC, “with a distribution network of 13 offices in Brazil, SyncMedical has the ability to establish medical device sales and marketing support for any U.S. based company looking to launch their products into Brazil and Latin America.”

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