Licensing Requirements - Medical Device Manufacturers and Distributors
Table of Contents
- Licensing Options
- Device Manufacturers
- Device Distributors
- Multiple Products
- Late Fees
- Exemptions from Licensing Fees
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 two 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.
| 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 |
| 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 two 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, whether 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.
| 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 |
| 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 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 devices at each licensed place of business.
| 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 |
| 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 devices at each licensed place of business.
| 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 |
| 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 the 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.