Applications and Forms - Medical Device Manufacturers and Distributors
For assistance with licensing, call 512-834-6727.
Medical Device Manufacturers Program Update
All applications with fees are to be sent to this address:
Department of State Health Services
Cash Receipts Branch – MC 2003
PO Box 149347
Austin, TX 78714-9347
Important Fee Information for Device Manufacturers and Distributors
Some of our fees decreased on Sept. 1, 2019.
The changes are on the applications you can download from this website.
The changes are in place for the online applications.
Please make certain you pay the fee listed on the application or renewal.
To ensure you submit the correct amount, please do ONE ofthe following if applicable:
- Apply online.
- Renew online.
- Download an application from this website.
Online Licensing Options
Medical device manufacturers and distributors may use the Regulatory Services Online Licensing System to apply for new (initial) licenses or to renew existing licenses.
At this time, we are unable to process applications online for minor amendment changes to a license, such as name or address changes. Multiple product licenses may not be obtained or renewed using the online licensing system.
- Initial, Renewal, or Change of Ownership - including legal entity (EF23-10621) (PDF, 255KB)
- Minor Amendment Change - Name, Address (EF23-13000) (PDF, 251KB)
- Initial, Renewal, or Change of Ownership, including legal entity (EF23-10858) (PDF, 231KB)
- Minor Amendment Change - Name, Address (EF23-13001) (PDF, 226KB)
Please see the Multiple Products applications on the Drug Manufacturers and Distributors website to apply for a multiple products license for two or more of the following:
- Non-Prescription Drugs
- Medical Devices
- Compressed Medical Gases