STD Med, Inc. Receives ANVISA Registration for Class III Medical Devices in Brazil
Published: Nov 09, 2012
STOUGHTON, Mass., Nov. 8, 2012 /PRNewswire/ -- STD Med, Inc. is pleased to announce that it has received a 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 after an intensive audit by the Brazilian agency of STD Med's manufacturing facilities. Currently this audit has a 2 to 3 year wait list and is one of the primary hurdles for new medical device product registration in Brazil.
Steven Tallarida, President of STD Med Inc. stated, "STD Med is one of the best middle market medical device manufacturers in the business and we look forward to bringing U.S. quality medical products into the South American healthcare system." Rafael Martinelli de Oliveira, President of BMR Medical, a Brazilian medical device commercialization and distribution company also added, "STD Med has been a manufacturing partner since 2006 and has always provided us with outstanding service and high quality products. They understand the Brazilian market and their willingness and ability to meet local requirements has always been a top priority. A result of this commitment to the Brazilian market is ANVISA GMP certification, which will allow us to launch new products faster and more efficiently."
SyncMedical LLC, a subsidiary of STD Med Inc., is uniquely positioned to further assist in establishing emerging new technologies in Brazil. With a distribution network of 13 offices in Brazil, SyncMedical has the ability to establish sales and marketing support in the Brazilian medical device market for any U.S. based company looking to launch their products into Brazil and Latin America.
As an approved manufacturer, STD Med can now provide their clients with the needed documentation to significantly shorten the regulatory approval process in Brazil. With a population of over 250 million people, Brazil's medical device market is in the top ten globally and with ANVISA certification, STD Med is poised to become a major producer of quality medical device products for the Brazilian marketplace. The addition of the ANVISA approval continues to identify STD Med, Inc. as a leading medical device company serving customers throughout the world.
About STD Med, Inc.
STD Med, Inc. is a rapidly growing and emerging leader in the development and manufacture of medical devices and precision machined components. Established in 1953, STD Med, Inc. is a privately held company with 3 facilities in Massachusetts which are ISO 13485:2003, ISO 9001:2008, JPAL and FDA approved. Over the past several years STD Med, Inc. has incubated and invested in several new technologies including Angiolink Corporation (acquired by Medtronic), Arthrosurface Inc., Spirus Medical, Inc.(acquired by Olympus) and Cardiosolutions, Inc. and it is our intention to continue to pursue disruptive innovation in the medical device marketplace.
SOURCE STD Med