Panoramic: Automotive and Mobility 2025
Medical device manufacturers who distribute prescription and over-the-counter (OTC) devices are subject to complex state licensing requirements that can attach to their manufacturing and/or distribution activity. Further, many medical device manufacturers partner with third-party logistics (3PL) providers that are also subject to separate state licensing requirements; all of which are separate from the business licenses that companies need to obtain to conduct business in the state.
Licensing rules vary between prescription and OTC devices, recipient, and location. There are even a fair number of states that have no licensure requirements for medical devices of any sort. Adding further complexity, most state licensing regimes are developed to handle prescription drugs and controlled substances and are not always suitable for the distribution models used for medical devices and are not always applied to medical devices.
Where medical device companies are required to hold state licenses, companies must complete complex initial licensing and renewal forms with variable requirements and guidelines. Additionally, many licenses come with associated process requirements that must be woven throughout the distribution processes that are often part of the company’s Quality Management System (QMS).
Our knowledge of manufacturer Quality System requirements and industry experience in the distribution of medical devices, gives us the type of background and experience to help you navigate this complex and varied area of compliance.
Our capabilities at a glance
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Ex-government policy advisors
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Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Key contacts
Representative experience
Assisted client in addressing state licensing for new product launches by identifying those states that required licensure and assisting the company in preparing those applications.
Negotiated enforcement discretion with states for medical devices where licenses may have been required under the letter of the law, but the states elected not to require licensure due to the low risk of the product and low benefit of licensure.
Assisted companies with developing remediation strategies and handling notices of violations from state regulatory bodies.
Assisted in the negotiation of distribution agreements with client distribution partners and 3PLs to ensure that state licensing obligations were met.
Awards and recognitions
Band 1 for Healthcare and Healthcare: Pharmaceuticals/Medical Products - District of Columbia
Chambers USA
2020
Highly Recommended for FDA Medical Devices
LMG Life Sciences
2019
Regulatory Firm of the Year
LMG Life Sciences Awards
2018-2019
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