Applications and Forms - Medical Device Manufacturers and Distributors

Medical Device Manufacturers Program Update
11/19/2021

EFFECTIVE IMMEDIATELY

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.

Make certain you pay the fee listed on the application or renewal.

To ensure you submit the correct amount, please do ONE of the 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.

Device Manufacturers

• Initial, Renewal, or Change of Ownership - including legal entity (EF23-10621) (PDF, 255KB)
• Minor Amendment Change - Name, Address (EF23-13000) (PDF, 251KB)

Device Distributors

• Initial, Renewal, or Change of Ownership, including legal entity (EF23-10858) (PDF, 231KB)
• Minor Amendment Change - Name, Address (EF23-13001) (PDF, 226KB)

Multiple Products

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
• Foods