Do you want to make a breakthrough in the U.S. market with food, cosmetics, medical devices, and PPE. You will need to obtain U.S. FDA Certification first for these products, regulated by the government.
This certificate safeguards public health by ensuring product safety. Since 1906, the FDA has protected consumers, impacting nearly 20% of global trade and overseeing over $2.7 trillion in products entering the U.S. market annually. However, you don’t have to travel to the US to get it! You can get it from India!
Let’s clarify how to obtain the US FDA certification in India and why it is important for boosting business growth.
Understanding US FDA Certification in India for Products
Such a certification is more of an asset for firms looking to enter the U.S. market. Some products need this certificate without fail. They are:
- Food Products
- Medical devices
- Medicine
- Electronic Products that Emit Radiation
- Cosmetics, including makeup products, perfume, lotions, and other toiletry products
- Some dietary supplements
- Beverages
- Tobacco Products
- Veterinary Products
If the products in your business fall under the category of one or the other mentioned above, you would need an FDA certification to conduct business in the USA.
Learn More: Find out list of FDA “approved” & “not approved” products
Requirements to Get the US FDA certification in India
Before you apply for the US FDA certification in India, you need to know about the standards of the FDA.
The FDA will not allow your business to enter the country if it does not meet their standards. It depends on the classification they have. You need the green light from the board itself. They do so to ensure that no product has any health risks associated with it.
When the FDA analyses your business they given out an FDA certification that determines the fate of your business. This certificate analysis document would have the following details:
- Ingredients of the product
- Quantities
- Purity
- Where and when the product was manufactured
There are quite a few advantages to this crucial FDA certificate.
8 Benefits of US FDA Certification
FDA certification provides consumers with peace of mind, assuring them that your product has undergone testing and meets FDA standards. Here are some key advantages of obtaining FDA certification:
For your business to get FDA approval, you have to apply and get the certificate. So, do you know how you can get the FDS certificate? Come, well guide you.
Method to Obtain FDA Certificate
Here’s how to apply:
- Pre-market review: Submit a premarket notification (PMN) with product details, safety, and labelling information.
- Registration and listing: Register with the FDA and list all products for export to the U.S.
- Labelling requirements: Ensure products have English labels and comply with FDA guidelines.
- Post-market surveillance: Monitor product safety through recalls and adverse event reports.
- Certificate of Registration: Obtain certification to export products to the U.S
Learn More: How to verify US FDA Certification?
Conclusion
Obtaining US FDA certification in India is a vital step for businesses aiming to enter the U.S. market. With the FDA impact on exports nearing 20% of global trade, this certification ensures your products meet safety standards, opening doors to a vast market. For more information on how to apply, visit E-Startup India and take your business global!
If you want any other guidance relating to the US FDA Certification, please feel free to talk to our business advisors at 8881-069-069.
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