Medical products distributors often fall under the jurisdiction of the Food and Drug Administration Center for Devices and Radiological Health at the federal level. In addition, more than 30 states require some type of licensure to distribute medical devices, however there is no standard set of requirements, processes, or stipulations, creating a confusing array of laws and regulations.
What Members Need to Know
HIDA supports a uniform national standard for licensing wholesale distributors of prescription and medical devices. A national standard will create a more streamlined and efficient way of doing business for wholesale distributors. Specifically, HIDA supports a tiered legislative and regulatory licensure approach for prescription device wholesalers that:
- Implements a national standard but allows individual states to continue to license wholesale distributors; and
- Does not require a separate prescription device license if the wholesaler has a pharmaceutical wholesaler license pursuant to the Drug Supply Chain Security Act (DSCSA).