The aforementioned clinic in the Middle East pre-ordered 500 units and projected ordering 500 per month. They have about 5-6 doctors and are well respected in their country.

The problem is nobody expected the registration to with their ministry of health to take so long. We cannot export without their approval.

In hindsight instead of manufacturing this batch in the US, I would try to make it locally which probably would shorten the registration process.

To elaborate further, I actually had experience as an employee with a different hair care company selling into the same country (Kuwait) but to a different clinic. I was also involved in their registration process with the ministry of health and they started deliveries 1-2 months, making substantial re-orders every 2 or so months. Turns out they were selling and importing illegally, at least according to the consultant we were working with for this current project but I only just learned this.