FDA Medical Device Registration

FDA Medical Device Registration Quick and Easy

GOL Solution provides medical device registration and listing services at competitive rates. Additionally, we offer US Agent services for foreign companies. Our annual fee for US Agent services is $250, and our fee for registration/listing assistance is $199. We offer the flexibility to list multiple devices and provide free assistance for updating registration/listing information.

Comprehensive FDA Medical Device Registration Services

1. General Rules for Importing Medical Devices to the USA:

All medical device facilities must register with the FDA, with foreign facilities requiring a US representative.
Registered facilities face annual registration fees or application fees for medical devices.
Mandatory reporters (manufacturers, device user facilities, and importers) must submit reports for adverse events and product problems.
Devices must comply with labeling regulations and be registered with GUDI (Global Universal Device Identification).
Manufacturers' facilities must adhere to Quality Systems for Medical Devices Standards like GMP or ISO 13485.

2. GOL’s Service Offering:

2.1. FDA Registration and Listing:

Ensure ongoing FDA registration compliance with our comprehensive services covering facility registration, renewal, registration fees, and medical device listings. Let us act as your U.S. Agent for effective communication if you are exporting products to the U.S.

2.2. UDI and GUDI Service:

Meet FDA standards for Unique Device Numbers (UDIs) with our expert assistance. We guide you through the data gathering process and submit your UDIs to the GUDID database. Our one-on-one professional support ensures a smooth and compliant experience.

2.3. Label and Product Review:

Ensure seamless FDA compliance for your medical devices with our regulatory specialists at GOL. We conduct a thorough review of your labels, ensuring compliance and providing suggestions for accuracy. Rely on our guidance through FDA requirements for enhanced understanding and proper labeling.

3. End-to-End Solution for FDA Medical Device Registration:

Contact us now to streamline your FDA medical device registration process and ensure compliance with U.S. regulations. Our experienced team is ready to assist you at every step.

Why Choose GOL Solution for Medical Device Establishment Registration and Listing?

Competitive fees

Fast processing

Transparent services, with no hidden charges or increased annual fees

Advice and guidance on the applicable regulatory requirements for your device

Assistance for device classification

FREE registration and listing services for our US Agent clients

No separate fees for device listing

Creation of cover sheet and PIN to help you process your FDA fees payment

FDA Medical Device Registration