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Licensing Requirements - Medical Device Manufacturers and Distributors


Table of Contents


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. A additional fee may be charged for online licenses.

Licenses may be renewed online during the eligibility period beginning 60 days prior to the license expiration date and ending on the license expiration date.

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

Medical device manufacturers may apply for a license online, or by completing and returning a license application form. Licenses are valid for 2 years unless amended, suspended or revoked. For assistance in completing applications, call (512) 834-6727.

“Manufacturer” means a person who manufactures, fabricates, assembles, or processes a finished device. The term includes a person who repackages or relabels a finished device. The term does not include a person who only distributes a finished device. “Finished Device” means a device, or any accessory to a device, which is suitable for use, whether or not packaged or labeled for commercial distribution.

Fee Schedule For Device Manufacturers

License fees are based on gross annual sales of ALL devices sales at each licensed place of business.

Fees for Device Manufacturers - Initial/Renewal License or Change of Ownership
Gross Annual Device Sales Licensing Fees
$0 – $499,999.99 $495 for each place of business
$500,000 – $9,999,999.99 $2,225 for each place of business
$10,000,000 or more $3,708 for each place of business
Fees for Device Manufacturers - Minor Amendments (Name, Address)
Gross Annual Device Sales Licensing Fees
$0 – $499,999.99 $240 for each place of business
$500,000 – $9,999,999.99 $1,080 for each place of business
$10,000,000 or more $1,800 for each place of business

Device Distributors

Medical device distributors may apply for a license online, or by completing and returning a license application form. Licenses are valid for 2 years unless amended, suspended or revoked. For assistance in completing applications, call (512) 834-6727.

“Distributor” means a person who furthers the marketing of a finished domestic or imported device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user. The term includes an importer or an own-label distributor. The term does not include a person who repackages a finished device or who otherwise changes the container, wrapper, or labeling of the finished device or the finished device package. “Finished Device” means a device, or any accessory to a device, which is suitable for use, hether or not packaged or labeled for commercial distribution.

Fee Schedule For Device Distributors

License fees are based on gross annual sales of ALL devices sales at each licensed place of business.

Fees for Device Distributors - Initial/Renewal License or Change of Ownership
Gross Annual Device Sales Licensing Fees
$0 – $499,999.99 $495 for each place of business
$500,000 – $9,999,999.99 $1,113 for each place of business
$10,000,000 or more $1,731 for each place of business
Fees for Device Distributors - Minor Amendments (Name, Address)
Gross Annual Device Sales Licensing Fees
$0 – $499,999.99 $240 for each place of business
$500,000 – $9,999,999.99 $540 for each place of business
$10,000,000 or more $840 for each place of business

Multiple Products

You may be eligible for a Multiple Products License if your firm distributes two or more of the following products: Food, Nonprescription Drugs, Compressed Medical Gases, and/or Medical Devices. A separate license is required if you are distributing Prescription Drugs (other than Compressed Medical Gases).

Fee Schedule for Distributors of Multiple Products (Including Medical Gases)

Note: License fees are based on COMBINED gross annual sales of food, drugs, and/or devices at each licensed place of business.

Fees for Distributors of Multiple Products (Including Medical Gases)- Initial/Renewal License or Change of Ownership
Combined Gross Annual Sales Licensing Fees
$0 - $199,999.99 $540 for each place of business
$200,000 - $499,999.99 $810 for each place of business
$500,000 - $999.999.99 $1,080 for each place of business
$1,000,000 - $9,999,999.99 $1,350 for each place of business
$10,000,000 $2,025 for each place of business
Fees for Distributors of Multiple Products (Including Medical Gases) - Minor Amendments (Name, Address)
Combined Gross Annual Sales Licensing Fees
$0 - $199,999.99 $270 for each place of business
$200,000 - $499,999.99 $405 for each place of business
$500,000 - $999.999.99 $540 for each place of business
$1,000,000 - $9,999,999.99 $675 for each place of business
$10,000,000 $1,012 for each place of business

Fee Schedule for Distributors of Multiple Products (Nonprescription Drugs)

Note: License fees are based on COMBINED gross annual sales of food, drugs, and/or devices at each licensed place of business.

Fees for Distributors of Multiple Products (Nonprescription Drugs)- Initial/Renewal License or Change of Ownership
Combined Gross Annual Sales Licensing Fees
$0 - $199,999.99 $520 for each place of business
$200,000 - $499,999.99 $780 for each place of business
$500,000 - $999.999.99 $1,040 for each place of business
$1,000,000 - $9,999,999.99 $1,300 for each place of business
$10,000,000 $1,950 for each place of business
Fees for Distributors of Multiple Products (Nonprescription Drugs) - Minor Amendments (Name, Address)
Combined Gross Annual Sales Licensing Fees
$0 - $199,999.99 $260 for each place of business
$200,000 - $499,999.99 $390 for each place of business
$500,000 - $999.999.99 $520 for each place of business
$1,000,000 - $9,999,999.99 $650 for each place of business
$10,000,000 $975 for each place of business

Late Fees

A person who files a renewal application after the expiration date must pay an additional $100. Any returned checks received after expiration date will be assessed the $100.00 late fee.


Exemptions from Licensing Fees

Businesses may be exempt from licensing fees if one of the following conditions are met:

1) The business engages ONLY in the manufacture or distribution of radiation machines which are devices or the manufacture or distribution of devices which contain radioactive materials, and is currently licensed or registered with the Texas Department of State Health Services, Radiation Control under §289.252 or §289.226, 25 Texas Administrative Code.

2) The business is a charitable organization as described in the Internal Revenue Code of 1986, §501(c)(3), or a nonprofit affiliate of the organization, to the extent otherwise permitted by law.

Last updated March 2, 2016