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I will do fda medical device registration and listing
Mary R
About this gig
Navigating US FDA regulations doesn't have to be overwhelming. A single mistake can lead to customs detentions, Amazon listing suspensions, or costly delays. I provide seamless, end to end FDA Medical Device Establishment Registration and Device Listing to get your products cleared smoothly.
Services Included:
- Official FDA Establishment Registration (Initial & Renewals)
- Proprietary Device Listing (Class I, Class II & Exempt)
- Product Code, Regulation & Classification Verification
- Device Identification Maintenance & Label Guidance
Protect your investment, secure your import permits, and scale your Amazon or retail sales with full regulatory peace of mind.
Ready to start? Device rules depend strictly on your product type. Message me right now before ordering to verify your classification and ensure a hassle free submission!
Get to know Mary R
Mary R
FDA Regulatory Compliance And Product Certification Specialist
- FromUnited States
- Member sinceApr 2026
- Avg. response time1 hour
Languages
English
I am a regulatory compliance specialist helping global brands launch seamlessly and sell risk free. I specialize in FDA food and supplement label reviews, medical device 510(k) registrations, and CPSIA/CPC certifications for Amazon approval. I protect your business from delays, violations, and listing suspensions, and keep your business selling smoothly. Order today!
Other Regulatory Compliance Consulting Services I Offer
FAQ
What details are required to begin the FDA registration and listing process?
To proceed, I need your business contact details, facility address, device commercial name, intended use, and existing classification details (if known).
Does this service cover both establishment registration and device listing?
Yes, I handle both the official establishment registration and the individual product listing for your medical device under FDA regulations.
Can you assist with Class I, Class II, and 510(k) exempt devices?
Absolutely. I properly classify your product and execute the corresponding registration and device listing workflow according to FDA rules.
Will my establishment registration and device listing be visible on the official FDA portal?
Yes, once processed, your registration status and listed devices will be publicly verifiable on the official FDA Establishment Registration database.
Does the FDA charge an official government annual fee for registration?
Yes, the FDA charges a direct annual establishment registration fee. My gig covers professional consultation, data preparation, and portal submission.
Should I contact you before placing an order?
Yes! Every medical device carries unique classification requirements. Please message me prior to ordering so we can discuss your exact product details.
