How to get a product approved by the FDA in India?

What Does the FDA Regulate?

Various products are on the FDA’s radar, be it food or cosmetic or medical devices. So, these items need proper safety checks and clear labels along with allergen details. Drugs require clinical trial data and pre-market approval. Medical devices go through testing for quality and performance. Each product type has specific rules, so you need to plan accordingly.

About 15% of the U.S. food supply comes from imports and that’s why exporters should not overlook compliances. Now, here is a step-by-step process covering all the mandatory factors—one should understand before jumping into this field.

Steps To Get US FDA Certification in India

Classify Your Product

The first step is identifying your product category. Classification tells you what steps to follow. Food products need labelling and safety compliance. Pharmaceuticals must have clinical trial data and stability testing. Medical devices need strict tests before they’re cleared. Knowing your category helps you avoid unnecessary confusion later.

Register Your Facility

Registering your manufacturing facility mainly requires you to submit processes and quality control details. Plus, renewing it every two years is also important. Around 30% of exporters struggle during the registration process due to not having proper documentation.

Labeling Your Product

Proper labelling is just as important as testing. Labels must list all ingredients, nutritional info, and allergens. The country of origin must also be clearly mentioned. If you miss even one detail, customs might delay or reject your product. This is why getting your labels right is non-negotiable.

Quality Control and Testing

Testing your product ensures it meets U.S. safety standards. Food items may need microbiological tests to detect harmful substances. Drugs go through stability testing to prove their shelf life. Medical devices must pass performance checks to ensure they work well. About 25% of exporters report issues in this area. Testing thoroughly can save you from big problems later.

Submit Required Documents

The final step is submitting all the necessary documents to the FDA.

These include:

Facility registration proof

Product Catalogue

Label samples

Product Test Reports.

Remember that submitting incomplete paperwork can lead to delays at customs, while providing everything on time ensures smoother approval.

Final Thoughts

There is a step-by-step process to get FDA product approval in India—careful planning is a must. Classifying your product while testing it thoroughly and then completing the document submission are some crucial steps that shouldn’t be taken casually at all. So, stay informed about rule changes and once approved, your product can access one of the world’s largest markets. That’s how you take your exports to the next level.

For more information book call consultation with experts at 8881-069-069