Free Sale Certificate: Requirements, Process & Documentation

• A Free Sale Certificate (FSC) is a mandatory export document proving your goods (medical devices, cosmetics, food) are legally sold in India and safe for use.
• Depending on the product, it is issued by the DGFT, CDSCO, or State Licensing Authorities.
• Without it, foreign customs may detain your shipment, as they need proof the product is not banned or harmful.

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Introduction

You have created a batch of herbal cosmetics or surgical items with the highest quality. The packaging is top-notch, the buyer in Vietnam or the UAE is on standby, and you have sent the shipment off with self-assurance. 

A frantic phone call comes to you two days later. Your package is being held up at the foreign customs. The authorities are not raising any questions about the quality of your product; instead, they are asking about its legal status. They straightforwardly want to know: "If this product is so good, do you really have the right to sell it in your country?"

At this point, a Free Sale Certificate becomes the most significant document in your export portfolio. 

For a large number of Indian exporters, compliance with regulations is like a maze. We often observe that the owners of businesses are confused between a Certificate of Origin and a Free Sale Certificate or are not sure whether to go to the DGFT or CDSCO. But the option of neglecting this document is not available. It is the passport for your products.

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What is a Free Sale and Commerce Certificate?

The Free Sale and Commerce Certificate is a kind of Free Sale Certificate granted by the DGFT (Directorate General of Foreign Trade) in India that is intended for specific purposes. Although the word "Free Sale Certificate" (FSC) is commonly used in a general way by people, there is still a precise distinction made in the government system:

1. Free Sale Certificate (FSC): Authorized by CDSCO or State Drug Controllers for the categories of Drugs, Cosmetics, and Medical Devices.
2. Free Sale and Commerce Certificate: DGFT provides it for everything else (Engineering goods, Consumer items, and Medical devices not under Drugs & Cosmetics Act).

What exactly does it certify?

This certificate proves to foreign customs that:

• The product is freely sold in India.
• The product is not restricted or prohibited for export under the Foreign Trade Policy.
• The exporter is a legitimate entity with a valid IEC (Import Export Code).

Important Note: Unlike the CDSCO certificate, the DGFT’s "Free Sale and Commerce Certificate" explicitly states that it does not evaluate the product for safety or efficacy. It only certifies that the product is "freely tradeable."

Who needs this specific certificate?

You need the DGFT Free Sale and Commerce Certificate if you are exporting:

• General Medical Equipment: Items used in hospitals such as hospital furniture, autoclaves, or simple tools that may not be included in the stringent "Notified Medical Device" list of CDSCO.
• Personal Care Products: Soaps, detergents, or hygiene products that are not strictly considered to be "drugs."
• Engineering & Consumer Goods: Pressure cookers, machinery, textiles, etc. where the importing country such as Africa or Latin America requires proof of local sale.

Key Details

• Issuing Authority: DGFT (Regional Authority).
• Validity: 2 Years (from the date of issue).
• Application Mode: Online via the DGFT website (e-RCMC module).
• Cost: Approx. ₹1,000 (Government fee).

How is it different from a standard FSC?

Feature	Free Sale Certificate (FSC)	Free Sale and Commerce Certificate
Issued By	CDSCO / State Drug Authority	DGFT
For Products	Drugs, Vaccines, Notified Medical Devices (Implants, Stents, etc.)	Non-Drug items, General Hospital Equipment, Consumer Goods
Focus	Safety & Quality (Certifies the product is safe/effective)	Trade Status (Certifies the product is legal to sell)
Acceptance	Mandatory for Regulated Markets (Global)	Accepted for General Import Clearance

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What is a Free Sale Certificate for Export?

A Free Sale Certificate (FSC) is an official paper that is needed for the export of goods from India to specific foreign countries. This document confirms that the products you are exporting are legally produced and are at the same time sold in the domestic market (India) without any restrictions.

Here is a straightforward breakdown of what it is and why it is necessary:

1. What does it certify?

It gives the foreign buyer and their government the following assurances:

• The product is neither banned nor limited in India.
• The product is secure for use (it is in accordance with India's safety and quality standards).
• You (the exporter) own a legitimate license to manufacture or market this product

2. Who asks for it?

It is mainly required by the importing country's Regulatory Authorities or Ministry of Health. 

• Common Destinations: Countries in Latin America, Southeast Asia, the Middle East, and Africa usually ask for an FSC to register the product in their country. 
• European/US Markets: They mostly have their own particular compliance standards (like CE Marking or US FDA), so FSC is not so frequent there but still occasionally asked for.

3. Which products need it?

While almost any product can get one, it is mandatory for items that impact human health:

• Medical Devices: (e.g., Syringes, Implants, IV sets) – Most critical category.
• Pharmaceuticals & Drugs
• Cosmetics: (e.g., Creams, Lotions, Soaps)
• Food & Dietary Supplements
• Ayush / Herbal Products

4. Who issues it in India?

The authority changes based on your product:

• Medical Devices and Cosmetics: The State Licensing Authority (SLA) or the Central Drugs Standard Control Organization (CDSCO) has issued permits for these categories.
• General Goods / Engineering Items: The Directorate General of Foreign Trade (DGFT) has issued the permit.
• Food Items: The Food Safety and Standards Authority of India (FSSAI) has issued the permit.

How to Get a Free Sale Certificate for Medical Devices?

The process of applying for a Free Sale Certificate (FSC) for Medical Devices is more stringent than that for general goods because it considers human safety. The process is dictated by the Medical Devices Rules, 2017.

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What is a Free Sale Certificate for Medical Devices?

Applying for a Free Sale Certificate (FSC) for Medical Devices is stricter than for general goods because it involves human safety. The process is governed by the Medical Devices Rules, 2017.

Here is the specific breakdown for Medical Devices.

1. Who Issues It? (The Class Rule)

Unlike general goods, you cannot just go to one website. You must apply based on the Risk Class of your device:

• Class A (Low Risk) & Class B (Low-Moderate Risk):
  • Authority: State Licensing Authority (SLA) — The State Drug Controller of the state where your factory is located.³
  • Examples: Syringes, thermometers, surgical dressings, simple cannulas.
• Class C (Moderate-High Risk) & Class D (High Risk):⁵
  • Authority: Central Licensing Authority (CDSCO HQ, New Delhi).
  • Examples: IVD kits, heart valves, implants, dialysis catheters.

2. Prerequisites (Before You Apply)

You cannot get an FSC if you do not have:

1. Valid Manufacturing License:
   • Form MD-5 (for Class A/B) OR
   • Form MD-9 (for Class C/D).
2. Approved Product List: The device must be listed on your manufacturing license.
3. Clean Track Record: You must declare that there are no pending legal actions or adverse safety reports against the device.

3. The Application Process (Step-by-Step)

For Class C & D (Central - CDSCO)

1. Login: Go to the CDSCO SUGAM Portal.
2. Navigate: Choose "Medical Device" > "Application for Free Sale Certificate".
3. Upload Documents:
   • Covering Letter: On company letterhead, clearly listing the devices.
   • Manufacturing License: Upload the valid license copy.
   • Notarized Undertaking: A legal affidavit on ₹100 Stamp Paper. It must state: "No action has been initiated against us due to adverse events, market complaints, or Not of Standard Quality (NSQ) reports."
4. Fee Payment: Pay ₹1,000 per distinct medical device category via the "Bharat Kosh" payment gateway (linked inside the portal).
5. Submission: Submit online.
6. Timeline: Processing usually takes 3-4 weeks.

For Class A & B (State - SLA)

• Online/Offline: Some states (like Gujarat, Maharashtra, Karnataka) have their own online drug control portals (e.g., Xln India). Others still accept physical files.
• Process: You submit the same documents (License + Undertaking + Fees) to your State Drug Controller.
• Note: Even if you apply online, many State Authorities require you to submit the physical "Hard Copy" of the application after uploading.

4. Fees & Validity

• Government Fee: ₹1,000 per medical device (category).
• Validity: The FSC is valid up to the validity of your Manufacturing License.
  • Note: If your manufacturing license expires in 6 months, your FSC will also expire in 6 months.

5. Crucial Difference: DGFT vs. CDSCO

• Do NOT apply to DGFT if your product is a regulated Medical Device (e.g., a stent, or syringe). DGFT will reject it or issue a "Free Sale & Commerce Certificate" which is often rejected by foreign Ministries of Health for medical products.
• Apply to DGFT only if your product is general hospital furniture or equipment that is not notified as a medical device under the Drugs & Cosmetics Act.

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Who Actually Needs a Free Sale Certificate?

Not every product requires this, but if your goods interact with human health or safety, you almost certainly need one.

For Manufacturers

If you produce the goods yourself, the onus is on you to prove your manufacturing facility is licensed. You cannot obtain a free sale certificate for export if your factory license is expired or if you don't hold a valid GMP (Good Manufacturing Practice) certification.

For Traders & Exporters

This is a common query we get at Silvereye Certifications: "I am just a trader; I don't own the factory. Can I get an FSC?"

Yes, but you must obtain the necessary permissions and data from the original manufacturer. You cannot apply for a free sale certificate DGFT on your own without linking the application to a licensed manufacturer’s details.

For Startups Launching Internationally

Startups often skip this step, thinking it’s only for big players. However, if you are sending samples to a distributor in Europe or Africa, they will likely ask for an FSC before they even sign a contract. It proves you are not a "fly-by-night" operator.

Industries That Commonly Need FSC

Medical Devices

This is the most critical category. A Certificate for free sale medical device is mandatory for almost all exports. Since medical devices (like syringes, implants, or diagnostic kits) carry high risk, foreign governments demand strict proof of safety. In India, this is usually governed by the Central Drugs Standard Control Organization (CDSCO).

Cosmetics & Personal Care

Whether it’s herbal shampoo or anti-aging cream, you need a free sale certificate for cosmetic products. Countries want to ensure the product doesn't contain banned chemicals like mercury or hydroquinone.

Food & Supplements

For food items and nutraceuticals, the FSSAI license is the base, but for export, you specifically need an FSC to prove the batch is fit for human consumption.

Electrical & Consumer Goods

While less common than in pharma, certain engineering goods require a free of sale declaration to prove they meet Indian safety standards (like BIS).

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Free Sale Certificate Benefits: Why This Single Document Changes Everything

Benefit	How It Helps Your Export Business
Builds Trust with Foreign Authorities	When a customs officer sees a document stamped by the DGFT or a State Licensing Authority, the scrutiny level drops. It validates that your business complies with the laws of a major economy like India.
Prevents Consignment Delays & Rejections	Speed is money in exports. An FSC ensures your shipment moves from the "Hold" pile to the "Cleared" pile. It eliminates the need for additional testing at the destination port, which can save weeks of waiting.
Enhances Brand Credibility	Displaying that you hold a Free Sale Certificate (CDSCO or DGFT) on your marketing materials signals quality. It tells potential buyers that you are not just a local seller, but a compliant global exporter.
Opens Doors for New Global Opportunities	Many government tenders in Africa and Southeast Asia make FSC a pre-qualification criteria. You cannot even bid for these lucrative contracts without having this certificate in hand.

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Requirements for Free Sale Certificate: What Documents Do You Need?

Getting the application right the first time prevents rejection. Here is what you generally need.

Company Registration Proof

• Import Export Code (IEC) issued by DGFT.
• GST Registration certificate.
• Valid manufacturing license (if you are the manufacturer).

Manufacturing / Trading License

For medical devices, a valid manufacturing license (Form 25/28) is non-negotiable. If you are a merchant exporter, you need a wholesale license and a relentless authorization letter from the actual manufacturer.

Product List or Brochure

You must provide a clear list of products for which you want the certificate. The product names on the FSC must match exactly with your invoice and packaging. Even a spelling error here can cause customs issues later.

Quality & Compliance Certificates

• GMP Certificate: Proof of Good Manufacturing Practices.
• ISO Certificate: Usually ISO 13485 for medical devices or ISO 9001 for general goods.
• Test Reports: Recent lab reports confirming the product meets safety standards.

Declaration & Supporting Documents

You will need to submit an affidavit declaring that the products are not banned in India and are freely sold in the domestic market. You may also need copies of export orders or invoices to justify the request.

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Step-by-Step Process: How to Apply for a Free Sale Certificate Without Stress

The process varies slightly depending on whether you are applying through the DGFT (for general items/medical devices not covered under specific acts) or State/Central Drug Authorities (for drugs/cosmetics).

Step 1: Check Eligibility

Identify which body governs your product.

• Medical Devices/Drugs: State Licensing Authority (SLA) or CDSCO.
• General Consumer Goods/Engineering: DGFT.
• Food: FSSAI or Export Inspection Council.

Step 2: Prepare Documents

Gather the checklist mentioned above. Ensure all licenses are valid. If your manufacturing license expires in a month, renew that first.

Step 3: Submit Application

• For DGFT: This is done online via the DGFT portal under the "e-RCMC" or miscellaneous application services. You will need a Digital Signature Certificate (DSC).
• For State Authorities: This is often a manual or semi-online process where you submit the file to the Drug Control Department of your state.

Step 4: Authority Review

The officer will verify your manufacturing capacity and past compliance record. They may cross-check your "free sale" claim by asking for domestic sales invoices.

Step 5: Approval & Certificate Issuance

Once satisfied, the authority issues the certificate. It will list your products and clearly state that they are "Freely Sold in India."

Expert Note: Always request two or three original copies. Foreign embassies sometimes retain one copy during the legalization process.

Easy Tip Section: Avoid Common Mistakes

• Mismatching Names: Ensure the product name on the FSC matches your Commercial Invoice letter-for-letter.
• Ignoring Expiry: Do not use an FSC that was issued based on a now-expired manufacturing license.

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How Long Does It Take? Validity, Processing Time & Fees Explained Clearly

Key Aspect	Details & Specifications
Average Processing Time	• DGFT: Usually fast, processed within 3 to 7 working days.• CDSCO / State Authority: Takes 10 to 20 days, depending on workload and inspection requirements.
Validity Period	Valid for 2 years from the date of issue OR until the expiry of your valid manufacturing license (whichever comes earlier).
Cost / Government Fees	The official government fee is nominal (typically ₹1,000 to ₹5,000), though the real investment is in the precise documentation and liaisoning required.
Fast-Track & Assistance	Agencies like Silvereye Certifications can manage drafting and submission to prevent rejections, often cutting processing time by half for exporters unfamiliar with the portals.

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Difference Between Free Sale Certificate & Other Export Certificates

Comparison	Other Certificate Details	Free Sale Certificate (FSC) Details
FSC vs COO (Certificate of Origin)	Proves Nationality: Confirms where the product was made (e.g., "Made in India"). Primarily required for claiming duty benefits or abiding by trade quotas.	Proves Legality: Confirms the product is safe and legal to sell in the domestic market. Required for regulatory clearance and safety verification.
FSC vs COPP (Certificate of Pharmaceutical Product)	Stricter Scope: A detailed, WHO-format certificate specifically for pharmaceutical drugs. It requires rigorous data on the drug's approval history.	Broader Scope: A general certificate used for medical devices, cosmetics, food, and engineering goods. It is less intense than a COPP.
FSC vs GMP(Good Manufacturing Practice)	Factory Focus: Certifies the factory conditions, hygiene, and manufacturing processes. It proves the facility is capable.	Product Focus: Certifies the specific product's status. It proves the item itself is legally sold and permitted in the market.

Common Problems Exporters Face – And How to Avoid Them Smartly

Application Rejection Reasons

The most common rejection reason is the failure to prove "Free Sale." If you are a 100% Export Oriented Unit (EOU) and do not sell in India, obtaining a standard FSC can be tricky. You need specific legal provisions to prove safety in lieu of domestic sales.

Documentation Errors

Submitting a blurred copy of the manufacturing license or an affidavit that isn't notarized are silly mistakes that cause week-long delays.

Country-Specific Complications

Some countries, like Vietnam or the Philippines, require the FSC to be attested by the Indian Ministry of External Affairs (MEA) and their own Embassy. A standard FSC without attestation will be rejected there.

Expert Tips to Ensure Smooth Approval

Always maintain a folder of "Domestic Sales Proof." Keep 5-10 invoices of your product sold to Indian customers handy. When the officer asks, "Do you really sell this here?", showing those invoices ends the debate instantly.

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Don’t Let Paperwork Stop Your Global Dream — Get Your FSC Today!

Exporting is about momentum. The last thing you want is for your momentum to crash against a wall of bureaucracy at a foreign port. A Free Sale Certificate is not just a piece of paper; it is your reputation stamp. It tells your buyers, "We are legitimate, we are safe, and we are ready for business."

Don't wait until your shipment is stuck to figure this out.

If you are finding the free sale certificate DGFT or CDSCO process confusing, or if you are unsure which authority applies to your specific product, we are here to help.

Need a hassle-free Free Sale Certificate?

At Silvereye Certifications, we handle the red tape so you can focus on growing your business. Contact us today for a quick consultation and let’s get your products moving across borders!

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Frequently Asked Questions