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Importing medical devices into the United States requires strict FDA compliance, and the stakes are massive. Medical device importers must ensure premarket compliance (510(k)/PMA), establishment registration and listing, proper CBP filing codes (DEV, LST, PM#), and ongoing MDR obligations. Foreign manufacturers need US agents while initial importers must maintain complaint files in the US. Products that don't meet requirements face detention, refusal, and destruction, often c

FDA requires medical device labeling to include manufacturer information, intended use, adequate directions, warnings, UDI (where applicable), and device-specific requirements. Labeling encompasses all written materials including labels, packaging, instructions for use, and promotional materials. Compliance requires both content accuracy and quality system controls under 21 CFR 820.120. This guide covers all FDA labeling requirements, common violations, and compliance strateg

Whether you need FDA approval, FDA clearance, or no regulatory submission at all depends on your device's risk classification and intended use. FDA approval (PMA) is required for high-risk Class III devices. FDA clearance (510(k)) is needed for most Class II devices and some Class I devices. However, most Class I devices and many Class II devices are exempt from premarket submissions but still require FDA registration and listing. This guide provides a complete decision frame

CMS New Technology Add-on Payment (NTAP) is the fastest path to Medicare reimbursement for by providing additional Medicare payments above standard DRG rates for qualifying new medical technologies. AI devices must meet three criteria: newness (within 2-3 years), cost adequacy, and substantial clinical improvement. NTAP can last up to 3 years (depending on newness) and can support adoption by reducing financial friction. This guide covers everything you need to know about NTA

The EU AI Act is a risk-based regulation requiring AI medical devices to undergo dual compliance, single integrated CE: NB assesses AIA + MDR/IVDR together. High-risk AI systems need notified body assessment, AI literacy training, and enhanced post-market surveillance. Medical devices get 36 months to comply (until August 2027), but AI literacy requirements already apply from February 2025. This guide covers everything you need to know about EU AI Act compliance for medical d

EU AI Act requires separate AI system certification alongside medical device approval, with 36-month implementation timeline. FDA's PCCP allows pre-approved change plans to modify AI devices without new submissions. Companies targeting both markets need dual strategies - EU compliance for safety-critical changes, PCCP for iterative improvements in the US. Here's how to choose the optimal regulatory strategy for your AI medical device's global success. The $500K+ Decision Ever