Want to export your products in the USA? Facing issues while complying with US Import and Export Formalities? Confusion in Preparation of Documents for US FDA Certification? Contact our professionals and get all the clearance required to fly off your products in the US and global market. You will receive the US FDA Certification delivered to you while sitting in India.
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If anyone wants to export the items such as Food, Drugs, Cosmetics, Color Additives, Medical Devices, Supplement, Even PPE Kit to the U.S.A, they must obtain US FDA Certification. The US FDA Certifications main purpose is to protect and manage public health in the United State of America. The US FDA also focuses on guaranteeing the security and protection of the biologically generated product.
The US FDA(Food and Drug Administration) was established in 1906 and is currently the government agency working under the Federal Food and Drugs Act. The FDA is one of the oldest agencies in the world for consumer protection. Thus, US FDA Certification becomes a valuable asset as well as a mandatory milestone to start expansion of your business in the U.S.A.
Following an examination by an FDA official, the FDA provides Form 483 for FDA Certification of the items. According to FDA rules, food and pharmaceuticals manufacturing facilities in India must follow Current Good Manufacturing Practices (CGMP).
The list of products that US FDA Regulates are biological products, medical services, cosmetics, prescription drugs and non-prescription drugs, veterinary drugs, tobacco and several other products such as radiation emitting machines etc.
US FDA Certification simply is a certificate to indicate that your product is safe and effective for use. It also indicates that the items being exported to the U.S.A are following the CGMP(Current Goods Manufacturing Practices) as set by the FDA Guidelines. All the businesses involved in the processing of food, drugs, medical devices, cosmetics must obtain US FDA Certification in India. If you fail in getting US FDA Certification, you can not enter into the U.S. Market.
The US FDA Certificate includes detailed and valuable information about the products standards as well as its quality or regulation. It also includes the name of the recipient company.
The US FDA Certification is a popular certification across the globe. Therefore it offers multiple advantages such as-
#1. US FDA Certification instills the trust in the heart of your customer. It isn't easy to get US FDA Certification in India. There are rigorous procedures, including site verification, involving US full time agents plus lengthy document preparation steps. Thus, if you get it, the customers start believing in your products quality and efficiency.
#2. The FDA Certified products become popular easily. Consumers realise that it has been well tested and is safe to use. As a result, demand for your goods will increase. Furthermore, the information about your products start spreading through word of mouth after receiving US FDA Certification.
#3. US FDA Certification isn't only valid for the USA only. The certification also provides business opportunities in other countries such as Japan, U.K., China, Australia etc. One can also export the products manufactured in the USA having US FDA Certification to other parts of the world.
#4. It will be much easier for your organisation to develop into other sectors of business after you have received US FDA Certification in India. You can use similar kinds of procedures used while obtaining US FDA Certification to develop the other items.
#5. Funds and Investment is an important part of business to keep it running smoothly. Getting a US FDA Certification in India indicates your products are worthy of investment. Hence, you can raise investment from multiple sources.
#6. Mostly US FDA Certifications are related to Medicinal Equipment and Products. Getting a US FDA Certification in India ensures your expansion in medical networks and also doctors and other hospital staff mostly prefer using only these products.
It is important to note that not every product you want to export in the U.S.A. requires US FDA Certification in India. However, there are several products in which without having US FDA Certification, you can not export them. The list of FDA Regulated Products which Requires US FDA Certification in India is mentioned below.
#1. Food Products
Food Items do not require FDA Certification. However, every Food Facility or FBO that stores, prepares, packages, serves, vends, or otherwise provides food for human consumption is required to have US FDA Certification in India. The US FDA Officials also visit the business establishments to evaluate the food and pharmaceutical manufacturing plants. As a result, they ensure the business complies with FDA Rules, Regulations and Standards. This also includes businesses dealing with Animal Food Products.
#2. Medical Devices and Equipment
Medical Devices and Equipment are an important product for every nation. They directly impact the health of the user. Therefore, the US FDA has decided to classify the medical devices and equipment that need US FDA Certification in India. These are described below.
- Class 1 ( Devices such as Elastic Bandages, Tongue Depressors, Face Masks etc.)
- Class 2 ( Devices such as Motor Wheelchairs, Pregnancy Test Kits, Apple Watch etc.)
- Class 3 (Devices such as pacemakers, breast implants, Heart Valve replacements etc.)
Here, Medical device makers should register with the FDA and supply FDA with a full list of their products. The FDA does not certify firms or devices based on their registration and listing with FDA. Thus, the organization needs to get US FDA Certification for the applicable products under all these three classes.
Important Note:- Anyone who wants to market a Class I, II, or III device intended for human use in the United States must submit a 510(k) to FDA unless the device is exempt from the 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in.9 of the device classification regulation chapters.
#3. PPE Kit
PPE applies to protective gear, helmets, gloves, face shields, goggles, facemasks, and/or respirators, as well as other devices meant to keep the wearer safe from damage or the transmission of virus or ailment. In health-care environments such as hospitals, doctor's offices, and clinical labs, personal protective equipment (PPE) is routinely employed.
When worn correctly, personal protective equipment (PPE) functions as a barrier between infectious elements. Depending on the kind of PPE, the FDA's regulations and consensus criteria differ. Therefore, PPE Kit manufacturers need to obtain US FDA Certification in India. The FDA reviews PPE Kits in India so they can be legally sold in the United States.
Both completed dietary supplement products and dietary components are regulated by the FDA. Dietary supplements are regulated by the FDA under a distinct set of rules than "standard" foods and drugs. It is illegal for manufacturers and distributors of dietary supplements and dietary components to advertise adulterated or misbranded products. This implies that these companies are responsible for assessing the safety and labelling of their goods prior to marketing to ensure that they fulfil all DSHEA, FDA laws and achieve US FDA Certification. Furthermore, the US FDA can take strict action if a supplement is adulterated or uses misbranding .
The FDA works in collaboration with CDER(Center for Drug Evaluation and Research) to ensure only the safe and effective drugs reach US Citizens. Tens of millions of individuals in the United States rely on prescription and over-the-counter pharmaceuticals to maintain their health nowadays, with more than four billion drugs prescribed each year.
Too many individuals, however, are hospitalised unnecessarily, and some are killed as a result of hazardous pharmaceutical mistakes. Thus, the US FDA evaluates the drugs manufacturing organizations and makes it mandatory to obtain US FDA Certification for them.
Cosmetic goods and components, with the exception of colour additives, do not require FDA clearance before entering the market. However, there are rules and regulations that apply to cosmetics sold in the U.S.A by other nations. Therefore, US FDA Certification and US FDA prevents adulteration of cosmetic products.
As per the U.S. FDA Regulations, Cosmetics are defined as "items intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for washing, beautifying, enhancing attractiveness, or modifying the look" under the FD&C Act (sec. 201(i)). Skin moisturisers, fragrances, lipsticks, fingernail polishes, eye and face cosmetics, cleaning shampoos, permanent waves, hair colours, and deodorants, as well as any ingredient intended for use as a component of a cosmetic product, are all covered in this description. Thus, businesses outside the U.S dealing with cosmetics need to apply for US FDA Certification.
#1. US FDA does not approve Health care providers, including physician offices, or laboratories
#2. Compounded drugs are not FDA approved.
#3. The transplantation of vascularized human organ transplants, such as kidney, liver, heart, lung, or pancreas, is not subject to regulation by the FDA and is not FDA Approved.
#4. Tobacco products are not approved by the FDA.
#5. The FDA does not approve cosmetics except color additives. (other than coal-tar hair dyes)
#6. The FDA doesn't approve medical foods.
#7. Infant formulas are not required to obtain FDA approval prior to being marketed.
#8. Dietary supplements are not subject to FDA approval.
#9. The FDA does not provide approval for the food label, including the Nutrition Facts label.
#10. The FDA does not grant approval for structure-function claims on dietary supplements and other foods.
The FDA's logo is exclusively intended for official government purposes.
It should not be utilized in a manner that distorts the agency's image or implies endorsement by the FDA of any private organization, product, or service.
The FDA logo is exclusively intended for official use by the U.S. Food and Drug Administration (FDA), and it should not be used on materials from the private sector.
Using the logo in such a context can mistakenly imply FDA endorsement of a private organization, its activities, products, services, or personnel, which it does not do.
So, Unauthorized use of the FDA logo is against federal law and may result in civil and/or criminal liability.
Following are some of the most important aspects to keep in mind while applying for US FDA Certification in India.
To apply for US FDA Registration from India, you must ensure availability of a full time US agent in the USA to receive notices, other FDA communications and timely respond.
The firm requesting clearance for US FDA Certification to commercialise a medicine is responsible for conducting laboratory and animal experiments on the drug's safety and effectiveness, and then submitting the results to FDA for assessment by CDER doctors, statisticians, chemists, pharmacologists, and other scientists.
For items controlled by the Food and Drug Administration, domestic enterprises exporting goods from the United States are also frequently required to provide a US FDA Certification by their overseas clients or governments.
Domestic and international organizations that manufacture, repackage, or re-mark medical products in the United States must register with the FDA. Domestic and international pharmaceutical manufacturers, repackers, and re-labelers must also declare all of their financially supported medical products. This information allows the FDA to maintain a database of all drugs in use in the United States.
The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-advertise disclosure framework for cosmetic item manufacturers, shippers, and dealers operating in the United States.
The FDA is in favour of electronic accommodations. FDA uses the FDA Unified Registration and Listing System(FURLS) to store such data electronically. Hence, you can get US FDA Certification in India online.
There are four major types of drug certification applications that can be applied to the US FDA. These are -
The US FDA Certification in India allows you to market and sell the products legally in the USA and other nations too.
The price you pay is quite less as compared to the benefits you avail for US FDA Certification.
US FDA Certification in India also aids in having a highly impactful trust of your products on Indian Consumers. As a result, your brand becomes the symbol of Credibility.
Whether you need more information on how to categorise your device or need US FDA Certification, you will definitely develop a relationship with FDA in order to get your product to market.
All foreign food, medicine, and medical device makers and exporters seeking US FDA Certification must designate a US FDA Agent. The FDA Agent designated in the U.S.A acts as a primary way of connection between your business in India and FDA in the U.S.A. The US FDA agent also acts as an emergency contact and routine certification demands.
The US FDA Agent must either be a US resident or have a physical presence or registered firm in the United States. Furthermore, a post office box cannot be used as an address by a US agent.
Important Note:- During normal business hours, either the US FDA Agent must be accessible to answer the phone or have an employee accessible for the same.
#1. Airway Bill & Invoice Bill of Lading
#2. Order for Purchase
#3. Specific Documentation for Each Commodity
#4. List of Items to Consider
#5. List of Growers
#6. Labelling Copies
#7. Documentation proving the identity of the product's true owner
#8. The declaration of the product's intended or final usage
#9. Any other documents that have been requested.
You can contact our business advisors at - 8881-069-069 for free and understand the Documents Requirement for US FDA Certification in detail.
E-startupIndia is a team of experienced professionals to assist you in getting US FDA Certification in India. Our team of experts can help you obtain US FDA Certification from beginning to end. From document preparation to final application approval, we are here to serve you with a variety of services so that your business can reach new heights globally.
Consultation with our experts for understanding the product you desire to export and trade in the USA .
Provide required documents and information for applying for US FDA Certification.
Our team will appoint the authorized or registered US FDA Agent in the U.S.A. File the application to the US FDA Department.
After the FDA Department and US FDA Officials successfully verified your business and the application, we will deliver your US FDA Certification in India.
Important Note: The verification process time may vary as it all depends on the US FDA Department and their officials.
Getting a US FDA Certification in India is not an easy task. Therefore, at e-startupindia we help you by connecting with business professionals that make this hassle free process for you. Now you don't have to be physically present at FDA offices in the USA , waste your time and energy preparing documents or even do tedious tasks of replying to objections or any other issues. With the assistance of e-startupindia, you can leave all your stress of registrations, licenses, or certifications for your business to us.
Our team of highly professional Chartered Accountants, Company Secretaries, and Lawyers works with fast-paced technology that takes care of all your major business requirements. Our qualified professionals are available to answer any questions you may have concerning the US FDA Certification in India. We believe that your business is our own and you are our family, thus we aspire to achieve the best possible results through minimal effort. Sky Rocket your business ventures with complete legal formalities and for affordable costs at the comfort of your own home. Don't hesitate to contact us anytime, we are here only for you!
Yes, the US Government wants official assurance that the product they are importing is safe and of high quality. Thus, Physical Verification shall be conducted by US FDA Officials at your business premises.
All firms not having a US presence must appoint a registered US FDA Agent. As per US FDA, the US FDA Agent must be either a Resident of the U.S.A. or should be having physical presence or place of business in the U.S.A. Moreover, the US FDA Agent should have US Company Incorporation.
Yes, US FDA Certification is required for each product. Domestic and foreign establishments that manufacture, repack, or re-label drug products are some essential products that must obtain separate US FDA Certification in India. To know more about which products need US FDA Certification, you can contact our team.
The US FDA Certification is awarded after successful verification by US FDA Officials. Thus, US FDA Certification in India can take anywhere between one week to eight months depending upon the official's visit.
You do not need to go to the USA to obtain US FDA Certification from India. You can apply for US FDA Certification in India from the comfort of your home through our web portal.
As per the US FDA Regulations, every facility is required to renew their US FDA Registration every other between the 1st of October and the 31st of December. If you do not renew the US FDA Registration in a timely manner, the US FDA may cancel your registration.
The FDA logo cannot be used without proper authorization or approval from the Food and Drug Administration (FDA). The FDA takes the unauthorized use of its logo seriously as it can mislead the public and undermine the agency's credibility.
Misuse of the logo can create confusion about the authenticity or approval of products, leading to potential health risks for consumers. Furthermore, the logo is a registered trademark and its usage is restricted.
Unauthorized use of the FDA logo is prohibited and may result in serious legal consequences.
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