Join Essenvia at RAPS Convergence 2026 — Booth #918
· Charlotte, 15–17 September
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Topic
Market registration
Planning and running registrations outside your home market — what to decide before filing, how approvals in one market shorten another, and what actually causes delay.
Letter to file, or new 510(k)? Working through FDA's change guidance
FDA's Change assessment framework
What delays device registrations in Brazil, Mexico and India
Filing in a new market
Why use a Regulatory (RIM) Platform to manage Product Registrations?
How a regulatory information management platform handles global registrations — centralised data, standardised submissions, and tracking requirements across markets.
Your Guide to European CE Mark for Medical Devices
Launching a new medical device is a highly regulated process whether you are looking to sell in the United States or other countries. To go to market within the European Union, you must first obtain a CE mark for your medical device. Please keep reading to learn about what a CE mark is, why it’s important, and how to get one.