USA FDA DEVICE REGISTRATION
What is USA FDA Device Registration?
Foreign and domestic establishments such as (a) Manufactures (b) Initial Exporters (c) Initial Importers of Medical Devices intended to be sold in the USA must register and list with the FDA. It is mandatory to designate FDA US agents by establishments located outside the USA for better communication with the FDA Authorities.
Benefits of USA FDA Device Registration
Who can be certified USA FDA Device Registration?
Disposable Syringes Needles
Document required for USA FDA Device Registration
The extent of Documented Information differs as per:
Role of Shamkris and Process of USA FDA Device Registration
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below: