MDD Options provides a hybrid distribution model for MedTech manufacturers, enabling them to bring their medical devices to the US market more quickly.
Our model allows manufacturers to retain control of the sales process, resources, and messaging, while MDD Options manages the business processes that facilitate sales transactions. Upon receiving their 510(k), PMA, or qualifying for exemption, foreign MedTechs require both a US Agent and an Initial Importer. The US Agent acts as a communication facilitator, whereas the Initial Importer has responsibilities for product complaints, and ensuring all safety regulations are met.
We eliminate the need for MedTechs to register with up to 24 state regulators before selling their products in those states. MDD Options assumes title of the product and, being registered with all state regulators, typically only needs to update the line card listing.
Manufacturers are required to register for sales tax in 46 states upon reaching nexus, which can be determined by transaction value, quantity, staff hiring, or acquiring premises. MDD Options oversees the entire process of sales tax registration, collection, exemptions, payment, and reporting. Additionally, 43 states mandate annual corporate income tax submissions, which our model eliminates for MedTechs.
We access healthcare systems, hospitals and other facilities through shared vendor qualifications and credentialing programs.
For foreign MedTechs we can also assist with setting up a US entity, and making introductions to experienced accountants, attorneys, risk managers, recruiters, employers of record, meeting planners and public relations experts who know MedTech.
MDD Options offers short-term flexible contracts, enabling manufacturers to secure long-term agreements with strategic partners or build their own teams while entering the market. We provide real-time access to customer interactions, and full data access for PMCF and other product assessments.
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