How Do You Know If Your Medical Device Needs State Licensing?

How Do You Know if Your Medical Device Needs State Licensing?

The medical device industry is growing, and we’re seeing the impact at Two Labs as more and more clients are asking us for support in launching their new medical device products. Additionally, we have observed a significant need for support among manufacturers and wholesalers who have already launched their medical devices but are not compliant due to a lack of state licensing.

The medical device industry is projected to grow 5.9% by 2030.

One area of planning that these clients are seeking advice on is state licensing. The process can be particularly daunting for those already out of compliance. For manufacturers who have launched without the necessary licenses, the urgency to rectify this oversight has intensified. Major wholesalers are halting shipments, creating a pressing need to expedite the licensing process to avoid lost sales opportunities.

Navigating the regulatory landscape for medical devices presents unique challenges due to the often ambiguous and vague state requirements. Many manufacturers and wholesalers mistakenly believe that they are exempt from licensing because their products do not contain prescription drug assets, and may still find themselves required to obtain licenses based on how states classify these products. This discrepancy can lead to significant legal and operational risks, including costly penalties and restrictions on future sales and shipments if non-compliance is revealed during an audit. Unlike other regulated products, most states have unclear or nonexistent guidelines in their statutes or regulations concerning medical devices, forcing manufacturers to proactively seek out this crucial information to avoid potential launch delays.

Two Labs’ experience and relationships with state regulators allow us to keep up with what isn’t in the fine print.

To date, at least 20 states currently do require device manufacturers to carry a license to distribute in their state. And although this information is hard to track down, it’s still the manufacturers’ responsibility to check those boxes.

Here are just a few examples. Texas requires a license, but only if it’s your home state. Maryland, New Jersey and Tennessee all require licenses, but the specifics vary for each one. And similar to typical drug licensing, these nuances depend on the relationships between the client, their CMO, and their 3PL. Or if a state is an FDA-approval state, that could also warp the process.

Navigating the licensing landscape can be as precarious as driving without insurance; it may seem feasible until you are required to provide proof of compliance. Therefore, it’s essential not to underestimate the importance of proper licensing, regardless of whether your product contains a drug component.

At Two Labs, we are committed to helping you understand and fulfill the licensing requirements in each state in which you plan to distribute your medical devices. Don’t let the complexities of state licensing slow down your business- you don’t need to spend time researching and cross-referencing with your device launch plan. We are here to expedite the process and ensure you can focus on what you do best: delivering quality medical devices to the market.

We’re here to support your success from clinical to commercial – and beyond.

How can we help you today?