CERTIFICATION IN INDIA

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

Reduced risk

Reputation

Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Who can be certified USA FDA Device Registration?

Shamkris Group

Injection

Shamkris Group

Testing Kits

Shamkris Group

Medical Furniture

Shamkris Group

Medical Equipment

Shamkris Group

IVD Instruments

Shamkris Group

Surgical Instruments

Shamkris Group

Dental Implants

Shamkris Group

Ortho Implants

Shamkris Group

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:

Time Frame

Task

Process

Step 1

Phase I

Step 2

Phase II

Step 3

Phase III

Step 4

Phase IV

Step 5

Phase V

FAQ

Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 1.227, for human or animal consumption in the United States must register with FDAfood– borne illness; and • Quickly notify facilities that may be affected.