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CIL provides US FDA Registration services in India. We are an ISO 17020 accredited inspection agency.
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)
Mr. AK Sharma (CDG Inspection Ltd)
Plot Number 37, IMT, Manesar, Gurugram, Haryana - 122051, India
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