Medical Device Manufacturers and Distributors

Important Notices:

September 13, 2024- Class 2 Device Recall, Integra LifeSciences Corp.
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
 

Safety Issue on Magellan Diagnostics Lead Care Testing Systems

View Information: FDA’s Ongoing Investigation of Inaccurate Result Associated with Lead Care Testing Systems

About the Unit

The Drugs and Medical Devices Unit is responsible for ensuring medical device manufacturers and distributors comply with minimum licensing standards established to protect the health and safety of the citizens of Texas.  To accomplish this objective, inspections of medical device manufacturers and distributors are conducted. If voluntary compliance with the licensing standards cannot be achieved, the Unit recommends regulatory actions when necessary. In addition, the Unit provides technical assistance to its licensees, answers inquiries from consumers and investigates complaints involving possible violations of the state requirements for medical device manufacturers and distributors.

Licensing

To become licensed as a medical device manufacturer or distributor visit the licensing requirements page, which outline options for online licensing and renewal as well as fee schedules and links to application forms.

Information on related licenses and certifications may be found by following the links below:

• Bloodborne Pathogen Control
• Certificates of Free Sale / Origin
• Drug Manufacturers and Distributors
• Multiple Product Licenses
• Tattoo / Piercing Studios

Replacement License Document

If you lost your license, follow the steps below to print a replacement document. You will need to know your license number or ownership name.

1. Visit the DSHS Online Licensing Services webpage.
2. Click on the “license search” link under the “Check License Status or Search for a License” category.
3. Select a search method.
4. Enter the required information denoted by a red asterisk (*).
5. Click the white checkbox next to “I’m not a robot” under the “Security Measures” section.
6. Complete the reCaptcha/Security prompts.
7. Click on the Search button.
8. Click on your ownership name.
9. Click the Print button on the lower right side of the screen.

Post this document in the location of your original license certificate.

If you need to update information on your license, email Foods Licensing Branch or Drug & Food Safety Licensing Branch for assistance.

This document does not extend your license expiration date. It maintains the same expiration date as the original document.