Manufacturers and distributors of Rx and OTC medical devices must be licensed or registered in any state that regulates medical device manufacturing and distribution companies. State licensing and registration requirements vary and navigating through complex regulations for every state is burdensome for companies.
Complete Compliance Solutions helps medical device manufacturers and distributors understand their OTC and Rx device licensing obligations and partners with medical device companies to secure required licenses.
Secure Your Manufacturer State Licenses for Medical Devices with Complete Compliance Solutions
How Do You Know if Your Medical Device Needs State Licensing?
The Complexities Surrounding State Medical Device Licensing Requirements
Medical device manufacturers and distributors are subject to Federal regulations administered by the US Food and Drug Administration (FDA). Companies generally understand their Federal medical device regulatory obligations. However, medical device companies may be unaware of increasingly complex and burdensome state regulatory requirements for the manufacturing and distribution of their medical device products.
While all states have regulatory programs governing drug manufacturers and distributors, regulation of medical device distribution is much less uniform across states. About half of all states regulate manufacturing and/or distribution of medical devices. And, for those states that regulate medical device companies, the regulatory scheme varies across every state.
Identifying requirements for state device manufacturer and distribution licenses is challenging as requirements tend to be vague and not immediately apparent. As further complication, the state agency responsible for oversight of medical device distribution varies across states. While, in most states, jurisdiction lies with the state Board of Pharmacy, delegation of licensing authority in other states has been granted to agencies such as the Department of Health or Food and Drug Safety Program.
Companies must dig through varied state regulations and guidance documents to assess their licensing obligations. Within those states that regulate RX or legend medical device manufacturers and distributors, states may also regulate OTC medical devices.
Further, the license type required will vary by state depending on the unique business model of the manufacturer and distributor. In some states, a medical device manufacturers license may not be required if the manufacturer contracts with a licensed medical device distributor . However, a handful of states require the medical device manufacturer hold a manufacturers license in addition to licensing the medical device distributor.
Given the complexities surrounding medical device state licensing, companies often find they need to consult licensing agencies directly to confirm licensing obligations based on their business model. These efforts are time consuming for companies concerned with avoiding delays in manufacturing and distributing medical device products.
Complete Compliance Solutions digs into state regulations for our clients to understand the nuances of every state's licensing requirement.
Avoid Costly Launch Delays & Other Penalties
The path to medical device development and Federal marketing approval is lengthy and costly. For companies that have achieved final approval and are ready to launch a new medical device product, overlooking required medical device state licensing obligations can result in unnecessary launch delays.
Medical device manufacturers and distributors must be licensed to manufacture and distribute into regulated states. Distributing without appropriate licenses or registrations may result in administrative actions, fines, and suspension of product shipments.
The process of applying for and securing required medical device state licenses can take several months. Medical device companies must plan ahead to ensure adequate time to secure licenses before distributing products.
We Help Medical Device Manufacturers and Distributors Obtain the Proper State Level Licensing
Complete Compliance Solutions works with clients to secure medical device licenses from start to finish.
Our process starts with understanding our client's unique business model. License types vary across every state and are based on specific business conditions. Licensing requirements depend on whether a manufacturer distributes their own product, contracts with a distributor, operates as a virtual manufacturer, or contracts with a third party logistics provider. We work directly with state agencies to identify licensing requirements for our client's particular business model.
Once needed licenses are identified, we work with clients to assemble required application information. State application requirements may include:
Proof of FDA Medical Device Establishment Registration
Past disciplinary and enforcement actions
FDA and state licensing agency inspection reports
List of medical device licenses held in other states
Fingerprinting and criminal background checks for key personnel
Proof of Secretary of State registration
We work with clients to complete and submit online and paper applications and assist with application fee payments. Careful tracking of each application is crucial to ensure processing of the application is advancing through the agency. We leverage our close relationship with state agency personnel to track application status and ensure agency questions and information needs are promptly addressed.
Once medical device licenses and registrations are issued, we assist clients with tracking license expiration dates and renewal requirements.
The CCS Difference
Our focus is solely on state pharmaceutical licensing. We take ownership over our client's state medical device licensing needs.
As a boutique-style firm, we offer a specialized focus that allows us to deliver services in a streamlined, cost-effective manner.
Our experts work directly with our clients to develop solutions tailored to meet each client's unique business needs and goals.
State Medical Device Licensing FAQ
How much does a manufacturer and distributor state medical device license cost?
Depending on the state agency, medical device license application and renewal fees can range from hundreds of dollars to a few thousand dollars. Medical device license fees are established by individual state Board of Pharmacies or delegated licensing authorities and can increase or decrease based on agency actions.
What is a Registered Agent required for a medical device licensing application?
A registered agent is an individual or agent designated by the LLC or Corporation on whom legal documents and official communications may be served to be forwarded to the LLC or Corporation. Registered agents are state-specific, and must be an individual resident of the state or a business entity with an office in the state.
Is a medical device manufacturer license required if a licensed distributor is used to distribute medical devices?
A medical device manufacturer license may be required in some states even if a licensed distributor is used to distribute the manufacturer's medical devices on behalf of the manufacturer. A handful of states regulate non-resident manufacturers whose devices are distributed into their state.
Understanding the Difference Between OTC and Rx Pharmaceuticals
OTC (over-the-counter) and Rx (prescription) pharmaceutical drugs are both types of medications, but they differ in terms of availability, regulation, and usage.