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Medical Device Manufacturers and Distributors

The Drugs and Medical Devices Group is responsible for ensuring that medical device manufacturers and distributors comply with minimum licensing standards established to protect the health and safety of the citizens of Texas. In order to accomplish this objective, inspections of medical device manufacturers and distributors are conducted. If voluntary compliance with the licensing standards cannot be achieved, the Group recommends regulatory actions when necessary. In addition, the Group 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.


In accordance with section 418.016 of the Texas Government Code, the Office of the Governor temporarily suspended all necessary DSHS statutes and rules pertaining to professional and business license or certification renewal applications, including the suspension of any late fees related to renewal for a period not to exceed 90 days for those programs that are listed below. 

The effects of this suspension are to:

  1. Waive any required late fees related to renewal for a period not to exceed 90 days; and
  2. Extend the term of any professional and business license listed below for a period of not more than 90 days to allow license/certificate holders affected by Hurricane Harvey time to submit the appropriate documentation and renewal fee. 

The Declaration is for:

Angelina, Aransas, Atascosa, Austin, Bastrop, Bee, Bexar, Brazoria, Brazos, Burleson, Caldwell, Calhoun, Cameron, Chambers, Colorado, Comal, DeWitt, Fayette, Fort Bend, Galveston, Goliad, Gonzales, Grimes, Guadalupe, Hardin, Harris, Jackson, Jasper, Jefferson, Jim Wells, Karnes, Kerr, Kleberg, Lavaca, Lee, Leon, Liberty, Live Oak, Madison, Matagorda, Montgomery, Newton, Nueces, Orange, Polk, Refugio, San Jacinto, Sabine, San Patricio, Trinity, Tyler, Victoria, Walker, Waller, Washington, Wharton, Willacy, and Wilson.

This suspension is in effect until terminated by the Office of the Governor or until the Hurricane Harvey disaster declaration is lifted or expires, whichever comes first.

The current status of a license may also be verified online.


Licensing

To become licensed as a medical device manufacturer or distributor, please 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:


Email Updates

Sign up to receive email updates about important changes to the Medical Device Manufacturers and Distributors Program. This feature will serve as a tool to increase communication with license holders regarding new information added to the website.

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Contact Information

For General Program Assistance

Email: Drugs and Medical Devices Group
Phone: (512) 834-6755
Fax: (512) 834-6759


For Licensing Assistance

Email: Drugs and Food Safety Licensing Group
Phone: (512) 834-6727
Fax: (512) 834-6741

Mailing addresses may be found on the contact page.

Last updated September 13, 2017