Regulatory Compliance
Our expertise in dealing with regulatory agencies and our familiarity with their requirements can be instrumental to your entry into the various Latin American nations. We can provide you with guidance regarding documentation required in each country, preparation and submission of the documents to the regulatory entity, and follow up and updates regarding the evaluation process.
INTRADE is registered with the U.S. FDA as an importer/distributor of non-FDA approved device.
This allows us the advantage of bringing to the U.S. devices which cannot be sold in the U.S. market. This special permit enables us to maintain stock as well as to consolidate shipments of related products, thus cutting down on delivery lead times, import costs and allows us to provide consolidated shipments to our distribution network.
INTRADE provides the cardiovascular device manufacturer with a multitude of services efficiently and effectively. Our knowledge and expertise in Latin America can be an instrumental asset to enter or expand into this market, which represents over 25% of worldwide sales of the medical industry.