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Medical Equipment FDA Registration Services - GOL Solution
Device Classification
Which Medical Device Pathway Applies to You?
The FDA regulatory pathway for your device depends on its risk classification. Understanding which pathway applies is the first step before registration.
We support this
510(k) Exempt
Lower-risk devices that don't require premarket notification, only facility registration and device listing.
We support this
510(k) Premarket Notification
Devices that must demonstrate substantial equivalence to an already legally-marketed device before entering the US market.
Not currently offered
PMA (Premarket Approval)
The most rigorous FDA pathway, required for high-risk or novel devices and involving clinical data review. GOL does not currently offer PMA services.
Not sure which pathway your device falls under? We help you determine your classification as the first step, before any registration work begins.
The Basics
General Rules for Importing Medical Devices to the USA
Understanding these requirements upfront prevents costly delays.
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All medical device facilities must register with the FDA, with foreign facilities requiring a US representative.
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Registered facilities face annual registration fees or application fees for medical devices.
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Mandatory reporters (manufacturers, device user facilities, and importers) must submit reports for adverse events and product problems.
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Devices must comply with labeling regulations and be registered with GUDID (Global Unique Device Identification Database).
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Manufacturers' facilities must adhere to Quality Systems for Medical Devices standards like GMP or ISO 13485.
Our Services
GOL's Service Offering
End-to-end support across registration, unique device identifiers, and label compliance.
FDA Registration and Listing
Ensure ongoing FDA registration compliance covering facility registration, renewal, registration fees, and medical device listings. GOL acts as your US Agent for effective FDA communication.
UDI and GUDID Service
Meet FDA standards for Unique Device Identifiers (UDIs) with expert assistance through data gathering and submission to the GUDID database, with one-on-one professional support.
Label and Product Review
Our regulatory specialists conduct a thorough review of your labels, ensuring compliance and providing suggestions for accuracy.
Full Coverage
End-to-End Solution for FDA Medical Device Registration
From classification through recall protocols, we cover the full lifecycle.
Label Consultation and GUDID Registration
FDA Facility and Device Registration
Adverse Event Report and Recall Protocol
US Representative Services
Why Choose GOL
Why Choose GOL for Medical Device Registration and Listing
Competitive, transparent fees
Fast processing with no hidden charges or increased annual fees, and no separate fees for device listing.
Regulatory guidance included
Advice on applicable regulatory requirements, assistance with device classification, and help creating your cover sheet and PIN for FDA fee payments.
Free services for US Agent clients
Free registration and listing services when GOL serves as your US Agent, with no separate device listing fees.
Ready to Register Your Medical Device?
Talk to our team about registration, GUDID, and label review for your device.