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US FDA Registration Services

Listing ID #6089946

25,000 - 35,000 / Piece
Get Latest Price
  • MOQ 1 piece
  • ISO 17020 Accredited Inspection AgencyISO 17025 Accredited Testing Laboratory
  • Business Type Service Provider
Preferred Buyer From : Anywhere in India

A non-US producer of medical devices or food items that wants to expand its services in the US market must first register with the US Food and Drug Administration. CDG Inspection Ltd is a top US FDA....
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Company Information

  • Member Since 3 Years
  • Nature of Business Service Provider
  • GST No. 06AAFCC0655B1Z8

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A non-US producer of medical devices or food items that wants to expand its services in the US market must first register with the US Food and Drug Administration. CDG Inspection Ltd is a top US FDA registration services provider that assures correct paperwork submission and allows clients to begin exporting their products at the appropriate moment from Gurgaon, Haryana.

US FDA Registration is mandatory for any company that manufactures, distributes, or imports food/medical products for human use. The registration process involves submitting detailed information about a company’s manufacturing facilities, quality control measures, labeling practices, recall procedures, and more. Being registered with the FDA also means that consumers know that they’re purchasing a safe product from an organization they trust.

 

In order to be able to sell a product in the United States, you need to register with the US Food and Drug Administration for US FDA Registration. This is a process that involves submitting an application and paying a fee. Every company that makes a product for sale in the USA is required by law to register with the FDA.

This assures that all items sold in the United States meet a set of quality criteria. FDA Registration benefits both consumers and companies. Those registered with the FDA are eligible for a variety of marketing advantages that might help them boost their overall business and exports to the USA as well as other countries.

The FDA regulates many products that are intended for human consumption, including food and medical devices. In addition to registering your product with them, you will also need to comply with all other applicable laws and regulations.

This includes following good manufacturing practices (GMPs), which are guidelines for how to manufacture products safely. When you register your product with the FDA, you’re confirming that it’s been tested and found to be safe for public use. You also have to include information about how to use the product, what results in you can expect from using it, and any possible side effects or risks.

The FDA registration procedure is a demanding task that demands patience and caution while entering and submitting facility information online. It’s critical to realize that customers are not simply seeking any firm; they want to be certain that the goods you are selling are reliable and secure. The FDA wants to be certain that you are able to produce items in a GMP facility and in an acceptable way with quality as a primary consideration.

The manufacturer’s information and the relevant person’s contact information must be submitted as the initial stage of the registration procedure. Additionally, you must disclose information on the manufacturing process, product specifications, product codes, regulatory numbers, and labeling information as necessary for the items.

Once the mandatory information’s submitted along with the DUNS number FDA will issue a Registration number. Cosmetics and Food Facility Registration are not published on the website whereas medical device and drug establishment registration details will be published on the FDA website. If they approve it, then congratulations! You can move on to the planning phase for exporting goods. Remember the exported goods must comply with FDA labeling regulations.

Step 1: Determine the product covered in the FDA Registration scope

The first step is to determine whether your product requires FDA registration. You can use the FDA’s Mobile Device Software Validation Tool to find out whether your software application or device is regulated by the FDA. Only healthcare products are covered by FDA.

Step 2: Appoint US Agent and Register the establishment / Facility

Step 3: Label Compliance and Good Manufacturing Practice (GMP)


Company Details close-icon

CDG is an independent technical service company and has expert knowledge and experience in providing: inspection & testing services. CDG has been providing inspection services continuously for more than 10 years.
Our core values are safety, quality, and integrity. We focus on delivering a total solution to any inspection needs while integrating our services with our customers’ operations and schedules. Through an independent and objective attitude we strive for customer satisfaction by providing services that not only meet but exceed expectations and international standards. With our expertise, we are more than capable to support our international clients. CDG’s philosophy is to provide individual attention to client sand to build long term relationships. We have a small business tradition where our reputation, integrity, quality and service is as important to us as our commercial returns.
Our main inspection services are :
Fire Safety Audit
Electrical Safety Audit
Factory Compliance Audit
Industrial Safety Audit
Pre-Production Inspection
During Production Inspection
Pre-Shipment Inspection
Third Party Inspection
Container Loading Inspection
Product Quality Inspection
Product Inspection Services
Racking System Inspection Services
Construction Safety Audit
Garment Inspection Services
Food Hygiene Inspection
Food Safety Inspection
Green Audit Services
Health and safety audit
Environmental Inspection Services
Home Inspection Services
First Article Inspection
Vendor Inspection Services
Supplier Audit Services
Supply Chain Security Audit
C-TPAT Audit Services
BIFMA Testing Services
US FDA Registration
GHP Audit Services
GMP Audit Services
GDP Audit Services
Ingress Protection(IP)Testing
Construction Safety Audit
CDG has over 10 years of experience across the sourcing and manufacturing sectors within Asia. We are now based in the emerging manufacturing powerhouse that is India as we have seen a strong shift from both small and large firms to this rapidly developing.
  • Nature of Business Service Provider
  • Number of Employees 20 - 50
  • Year of Establishment 2003
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Looking for US FDA Registration Services?

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US FDA Registration Services at Rs 25,000 / Piece in Gurugram - ID: 6089946
Products / Services
  • Products / Services
  • Companies
  • Buy Leads
Post Buy Requirement

US FDA Registration Services

Listing ID #6089946

25,000 - 35,000 / Piece
Get Latest Price
  • MOQ 1 piece
  • ISO 17020 Accredited Inspection AgencyISO 17025 Accredited Testing Laboratory
  • Business Type Service Provider
Preferred Buyer From : Anywhere in India

A non-US producer of medical devices or food items that wants to expand its services in the US market must first register with the US Food and Drug Administration. CDG Inspection Ltd is a top US FDA....
View More Details
Send Enquiry

Company Information

  • Member Since 3 Years
  • Nature of Business Service Provider
  • GST No. 06AAFCC0655B1Z8

Ask for more detail from the seller

Contact Supplier

Service Details no_img_icon

A non-US producer of medical devices or food items that wants to expand its services in the US market must first register with the US Food and Drug Administration. CDG Inspection Ltd is a top US FDA registration services provider that assures correct paperwork submission and allows clients to begin exporting their products at the appropriate moment from Gurgaon, Haryana.

US FDA Registration is mandatory for any company that manufactures, distributes, or imports food/medical products for human use. The registration process involves submitting detailed information about a company’s manufacturing facilities, quality control measures, labeling practices, recall procedures, and more. Being registered with the FDA also means that consumers know that they’re purchasing a safe product from an organization they trust.

 

In order to be able to sell a product in the United States, you need to register with the US Food and Drug Administration for US FDA Registration. This is a process that involves submitting an application and paying a fee. Every company that makes a product for sale in the USA is required by law to register with the FDA.

This assures that all items sold in the United States meet a set of quality criteria. FDA Registration benefits both consumers and companies. Those registered with the FDA are eligible for a variety of marketing advantages that might help them boost their overall business and exports to the USA as well as other countries.

The FDA regulates many products that are intended for human consumption, including food and medical devices. In addition to registering your product with them, you will also need to comply with all other applicable laws and regulations.

This includes following good manufacturing practices (GMPs), which are guidelines for how to manufacture products safely. When you register your product with the FDA, you’re confirming that it’s been tested and found to be safe for public use. You also have to include information about how to use the product, what results in you can expect from using it, and any possible side effects or risks.

The FDA registration procedure is a demanding task that demands patience and caution while entering and submitting facility information online. It’s critical to realize that customers are not simply seeking any firm; they want to be certain that the goods you are selling are reliable and secure. The FDA wants to be certain that you are able to produce items in a GMP facility and in an acceptable way with quality as a primary consideration.

The manufacturer’s information and the relevant person’s contact information must be submitted as the initial stage of the registration procedure. Additionally, you must disclose information on the manufacturing process, product specifications, product codes, regulatory numbers, and labeling information as necessary for the items.

Once the mandatory information’s submitted along with the DUNS number FDA will issue a Registration number. Cosmetics and Food Facility Registration are not published on the website whereas medical device and drug establishment registration details will be published on the FDA website. If they approve it, then congratulations! You can move on to the planning phase for exporting goods. Remember the exported goods must comply with FDA labeling regulations.

Step 1: Determine the product covered in the FDA Registration scope

The first step is to determine whether your product requires FDA registration. You can use the FDA’s Mobile Device Software Validation Tool to find out whether your software application or device is regulated by the FDA. Only healthcare products are covered by FDA.

Step 2: Appoint US Agent and Register the establishment / Facility

Step 3: Label Compliance and Good Manufacturing Practice (GMP)


Company Details close-icon

CDG is an independent technical service company and has expert knowledge and experience in providing: inspection & testing services. CDG has been providing inspection services continuously for more than 10 years.
Our core values are safety, quality, and integrity. We focus on delivering a total solution to any inspection needs while integrating our services with our customers’ operations and schedules. Through an independent and objective attitude we strive for customer satisfaction by providing services that not only meet but exceed expectations and international standards. With our expertise, we are more than capable to support our international clients. CDG’s philosophy is to provide individual attention to client sand to build long term relationships. We have a small business tradition where our reputation, integrity, quality and service is as important to us as our commercial returns.
Our main inspection services are :
Fire Safety Audit
Electrical Safety Audit
Factory Compliance Audit
Industrial Safety Audit
Pre-Production Inspection
During Production Inspection
Pre-Shipment Inspection
Third Party Inspection
Container Loading Inspection
Product Quality Inspection
Product Inspection Services
Racking System Inspection Services
Construction Safety Audit
Garment Inspection Services
Food Hygiene Inspection
Food Safety Inspection
Green Audit Services
Health and safety audit
Environmental Inspection Services
Home Inspection Services
First Article Inspection
Vendor Inspection Services
Supplier Audit Services
Supply Chain Security Audit
C-TPAT Audit Services
BIFMA Testing Services
US FDA Registration
GHP Audit Services
GMP Audit Services
GDP Audit Services
Ingress Protection(IP)Testing
Construction Safety Audit
CDG has over 10 years of experience across the sourcing and manufacturing sectors within Asia. We are now based in the emerging manufacturing powerhouse that is India as we have seen a strong shift from both small and large firms to this rapidly developing.
  • Nature of Business Service Provider
  • Number of Employees 20 - 50
  • Year of Establishment 2003
Tell us your Buy Requirement to Get Instant Response
Tell us what you need?

Looking for US FDA Registration Services?

Quantity
Contact Details
Waiting for permission
To search by voice, go to your browser settings and allow access to microphone

Allow microphone access to search with voice