We are an aligner/invisible braces manufacturing company having our head office in *** and manufacturing unit in ***. We would like to expand our business to *** and *** where we would like to sell our products directly to consumers as explained below:
1- A patient will order impression kit and take his/her impression by his/herself and send it back to the company
2-Company then prepares a treatment plan with the help of dentists and orthodontists and send the plan back to the patient for approval.
3- After approval, company will manufacture aligners and send it to the patient.
The whole process is monitored by dentists/orthodontists.
The same model is being implemented in many countries worldwide, a few examples are ***, ***, ***, etc.
Our question is that are we legally allowed to follow the same model in *** and *** by the health authorities or by ISO standards.