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Querist : Anonymous

Querist : Anonymous (Querist)

26 February 2013 Hi,
I want to be a merchant exporter,And want's to Export Orthopedic Implants & Instruments.
I am having confusion regarding FDA certificate, Manufacture are using FDA certificate while doing this Export. Is there any way for merchant exporter to export Orthopedic Items, without using FDA certificate.

kindly give feedback ASP.
Or Mail Me sandy_00793@yahoo.com

RAMESH KUMAR VERMA

RAMESH KUMAR VERMA (Expert)

27 February 2013 FDA’s activities in India are to ensure that food and medical products exported from India to the U.S. are safe, are good quality, and are effective; these efforts include obtaining better and more robust information to help FDA officials in the various FDA headquarter Offices and Centers and at the borders make better decisions about products from India that are being developed for the U.S. market. This includes products being reviewed for marketing authorization in the U.S., and that are already on the U.S. market. To this end, FDA activities in India include: engaging with Indian counterpart regulatory authorities to ensure the timely exchange of information regarding clinical trials that are conducted that support marketing applications in the U.S.; partnering with Indian counterpart agencies on various bilateral and regional capacity building initiatives; working with regulated product industries in India that wish to export their products to the U.S. to assure their understanding of our standards and expectations regarding FDA-regulated products; coordinating and collaborating daily on product quality and safety issues with other U.S. government agencies that have complementary missions to assess conditions and events in those areas that might have an impact on the safety and quality of FDA-regulated products being exported to the U.S.; increased FDA inspections of relevant high-risk facilities; and by working with private- and public-sector entities that wish to engage with FDA on third-party certification efforts regarding these products.

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