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Registration Services

In order to begin manufacturing and/or distributing medical devices in the US or Europe, a company must first go through a series of steps that are collectively referred to as registration. The governing bodies in the United States and Europe require different processes. QSOne, Inc. is able to assist you in the registration processes of the United States and/or Europe regardless of your company’s location.

Within the United States, the process for the regulatory approval of medical devices is dependant on the device’s classification.

Class I devices are the least complicated and present the least risk. The device cannot be not life-supporting or life-sustaining or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury. Class I devices are only subject to the FDA’s general controls. General controls include an establishment’s FDA registration, product listing, compliance with the FDA’s Quality System Regulations and compliance with the FDA’s Medical Device Reporting regulations.

Class II devices are more complicated and present greater risks than Class I devices. Class II devices are subject to the general controls listed above as well as special controls that may include one or more of the following: specific performance standards, post market surveillance, and pre-market notification requirements (510 (k)).

Class III devices present the greatest risk and are generally life supporting or life sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. These devices are subject to all the controls as a Class II device as well as an IDE (Investigational device exemption) and Pre-market Approval (PMA).