Medical device manufacturers within the state must be licensed, and a separate license must be obtained for each place of manufacture. All manufacturers are subject to licensing unless specifically exempted. Exemptions currently exist for pharmacies that manufacture in the course of their regular business of dispensing at retail, licensed practitioners who manufacture in the course of their professional practice, persons who manufacture for noncommercial use in nonclinical research or in teaching, state-registered dispensing opticians who manufacture in the course of the business of dispensing or selling frames or lenses at retail, and dental laboratories. Please find the links to the Medical Device Manufacturing License Applications below. If you have the Adobe reader installed on your computer, you may fill out these forms online; however, you must print the completed form out, sign the form, and mail it in to the listed address. The online Adobe form cannot be directly submitted to the Food and Drug Branch and your content that you enter on the form will not be saved online.
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