Solutions Circles Know Before You Go: • Tickets are required and can be picked up at the Solutions Circle check-in desk 20 minutes before start (first-come, first-served). • Max 30 participants per session. Seats cannot be held in between sessions. • Arrive early. Your seat is only held for 3 minutes after a session starts, then released to standby attendees. • Open to full conference registrants only - have your badge ready. • Located in the Exhibit Hall, booth 200.
Proposal Description: Some US states require companies who manufacture or distribute prescription medical devices to hold licenses in their states. Device companies often think these requirements only apply to prescription drugs, but these states have defined their licensing requirements to include prescription medical devices.
Failure to comply with the state licensing requirements can result in significant fines and cease & desist orders that can interrupt your product from being distributed. Furthermore, any action taken by one state must be reported to all other states, many of whom are likely to also act against your company.
Requirements for licensing vary by state and product. In some states, only companies that distribute combination devices including drugs are required to be licensed; in other states, all prescription devices require a license; and in yet others, even contract manufacturers may be required to get a license.
Licensing can be a complex task, with manufacturers being required to get multiple licenses per state depending on the products involved, identifying an individual accountable for compliance, and requiring renewal every 1-3 years or whenever company ownership or officers change. It becomes easy to miss a requirement or renewal, costing your department time, money, and credibility.
In this seminar, participants will learn about state prescription licensing requirements, including the regulations and framework; the differences in approach and enforcement by state; and how to design a process to ensure your company is able to identify needed licenses, apply with the states efficiently, and maintain your licensure to remain up to date and compliant. We will also evaluate various options for achieving and maintaining licensure, including having an in-house team; using “turnkey” solution providers; or outsourcing to low-cost vendors.
NOTE: This seminar will be focused on the requirements as they apply to medical device manufacturers and distributors, not for pharmaceuticals.
Learning Objectives:
Upon completion of this session, participants should be able to identify the factors required to determine where licenses may be necessary for their companies, and the risks of non-compliance.
Upon completion of this session, participants should be able to understand how to apply for licenses with state licensing agencies, including resources needed, costs, and timing.
Upon completion of this session, participants should be able to create a process to maintain licenses going forward, including to manage changes.
.jpg "Amar Chanani, RAC: Devices, PMP, CMQ/OE, CSQE, CRE, CQE, CQA photo")