Distributor offers to take the burden, time, and cash concerns of filing your regulatory for you in a foreign land may sound nice. The problem is that by agreeing to this, you may have avoided some things, but you’ve simultaneously doomed your company and product line in one fell swoop. If your distributor owns your regulatory license, that means you cannot break-up for the under-performance issue you may not see coming. At least not without potentially handing over huge sums of money for a complete “redo” of your filing. Ouch. We refer to this as The Golden Handcuffs.
For Medical Device regulatory strategy, and the cost/benefit of filing yourself, using a 3rd party group, or allowing the distributor to file is a game-changer. You must balance today’s “win” with the company you will become in the future. Goalpost Global arms companies to accelerate long-term profitable international sales, all while giving you a proven plan to avoid the mistakes that could wipe it all away.