Certification and Registration
FDA US. Medical Device Registration
Category:
FDA Medical Device
In the United States, any enterprise engaged in the production and distribution of medical devices intended for commercial distribution in the United States, including imported medical devices intended solely for export, must complete annual registration with the US. Food and Drug Administration (FDA) every year.
In addition, most enterprises that are required to register must also list the medical devices they manufacture.
FDA medical device registration ensures that your enterprise is recognized as a compliant entity, that your devices are traceable and legally marketable, and that FDA has access to important data for public health supervision.
The True Meaning of FDA US. Medical Device Registration
FDA US. medical device registration is not a marketing procedure, but a mandatory legal obligation. This registration consists of two components:
(1) FDA Establishment Registration: This refers to registering your facility or business with the agency, confirming who is responsible for the manufacture, distribution, or importation of the device.
(2) FDA Medical Device Listing: Device listing involves submitting detailed information about each specific medical device you intend to sell.
Establishment registration and device listing together form the fundamental institutional framework for FDA to regulate the medical device market, track product distribution, and respond to safety incidents. Both are necessary for legal distribution in the United States.
Which Entities Need to Register?
The following entities must complete FDA registration:
● Manufacturers: entities that manufacture finished devices intended for commercial distribution within the United States
● Initial distributors: entities that first distribute devices within the United States
● Repackagers and relabelers
● Importers and exporters
● Specification developers: enterprises that develop specifications but outsource production
Special Note for Foreign Enterprises: If you manufacture devices outside the United States, you must complete FDA registration and designate a US. Agent to serve as the contact person for communication with FDA.
Three Risk Classes in the FDA US. Medical Device Registration Process
The US. FDA medical device registration process is divided into different classes according to risk level:
● Class I medical devices: low risk (type of regulatory control: general controls)
Products must comply with general regulatory requirements. Most can be directly registered without submitting product safety and effectiveness reports;
● Class II medical devices: moderate risk (type of regulatory control: general controls and special controls)
Products must meet the corresponding performance standards. Before registration, most products must submit a 510(k) premarket notification application to FDA and provide a demonstration report on product safety and effectiveness. Only after obtaining FDA clearance can the product be registered and legally marketed for sale. The application cycle usually takes more than six months.
● Class III medical devices: high risk (type of regulatory control: general controls and premarket approval)
This class of products is subject to the strictest regulatory requirements and must obtain formal FDA approval before marketing. The vast majority of products must first submit a PMA premarket approval application. Only after FDA review and approval can product registration be completed and the product legally enter the US. market. The application cycle is usually no less than one year.
It should be specially noted that before a PMA application is approved, FDA will conduct an on-site audit of the manufacturer’s factory quality system (FDA GMP QSR820). The manufacturer must pass this audit before FDA can formally approve its PMA application.
FDA US. Medical Device Registration Process
●Confirm product classification and class:
Determine the classification of the medical device, Class I, Class II, or Class III, and the corresponding regulatory pathway according to FDA’s product classification database.
●Product registration plan and confirmation:
SATISFY evaluates and confirms the registration plan based on the product information and documents provided by the enterprise for FDA medical device registration.
●Complete FDA establishment registration and device listing:
Handle medical device Establishment Registration and Device Listing, and obtain the FDA registration number.
●Designate a US. FDA medical device agent
Foreign enterprises must designate a US. Agent, who shall perform the following responsibilities:
(1) Assist FDA in communicating with the foreign principal enterprise;
(2) Assist FDA in understanding information related to medical devices imported or intended to be imported into the US. market by the principal enterprise;
(3) Assist FDA in arranging factory inspections of the principal enterprise’s production site;
(4) If FDA is unable to contact the foreign enterprise directly or in a timely manner, relevant information or documents may be provided to the US. Agent. This shall be deemed as FDA having delivered such information or documents to the principal enterprise.
Special Note: The US. Agent does not assume responsibility for medical device adverse event reporting.
For foreign enterprises, the US. Agent is not only a procedural requirement, but also a necessary condition for compliance. The US. Agent must have a physical address in the United States and serve as the primary contact point between the enterprise and FDA. They need to promptly relay FDA inspection requests or adverse event notifications. Choosing a reliable US. Agent is crucial.
SATISFY can provide FDA medical device registration services and US. FDA Agent services, dedicated to helping enterprises enter the US. medical device market efficiently and compliantly. For more details, please contact SATISFY customer service.
Previous page
Related Information
SATISFY TECH AND SERVICE LLC
SATISFY TECH AND SERVICE LLC delivers full-lifecycle technical solutions for children’s products, hygiene care, protective equipment, furniture, and building materials. Our framework spans compliance pre-assessment, standard upgrading, and risk control. We empower manufacturers and exporters through expert testing, certification, consulting, and standards interpretation.
Contact Us
Address: Room 7D, Building A, Zhongzhou Holdings Financial Center, No. 88 Haide 1st Road, Haizhu Community, Yuehai Subdistrict, Nanshan District, Shenzhen
Phone: 0755-8273-9683
Mobile: 189-2676-2893
Email: info@sdswcn.com
Sales Window
WeChat Applet