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
Certified USA FDA Device Video
Who can be certified USA FDA Device Registration?
Injections
Testing Kits
Medical Furniture
Medical Equipment
IVD Instruments
Surgical Instruments
Dental Implants
Ortho Implants
Disposable Syringes Needles
Document required for USA FDA Device Registration
- Technical File, Product Master File (TCF)
- Product Testing
- System Manual
- System Procedure
- FDA Manufacturing License
- WHO GMP Certificate
- Free Sale Certificate
- Objectives
- Plant Master File
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
- Mission & Vision
- Policy
The extent of Documented Information differs as per:
- Import Country Requirements
- Product and it's uses
- Composition of the product
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:
Step 1
Phase I
• Selecting the Medical Device and Models for USFDA approval
Step 2
Phase II
• Identify device code and Regulation Number along with verification of predicate device, indication and technology
Step 3
Phase III
• 510K compilation incorporating the pre-submission
Step 4
Phase IV
• US Agent appointment
Step 5
Phase V
• Modify the 510K and provide additional supporting documentary evidences as per FDA review comments.
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 FDA. food� borne illness; and � Quickly notify facilities that may be affected.