A Free Sale Certificate is the document an overseas regulator asks for when it wants proof that the device you are offering them is already approved and sold in its country of origin. For an Indian manufacturer exporting medical devices, it is issued by the drug regulator, and it is the item most often discovered late — usually when a foreign distributor’s registration file comes back incomplete.
What a Free Sale Certificate is
An FSC is an official certificate confirming that a medical device is manufactured in India and freely sold in the Indian market under a valid regulatory approval. CDSCO guidance also refers to it as a Certificate for Export. Importing countries use it as evidence that the device is not experimental, not restricted and not withdrawn at home.
It certifies status, not quality. It is not a test report, not a certificate of conformity, and it does not replace the registration the importing country requires in its own right.
Who issues it — and it depends on your device class
This is the point most often got wrong. Under the current CDSCO guidance (CDSCO/MD/GD/FSC/01/2024), the application goes to the Central Licensing Authority or the State Licensing Authority as the case may be:
- Class C and Class D devices — apply to the Central Licensing Authority.
- Class A and Class B devices — contact your respective State Licensing Authority.
In practice this usually tracks whoever granted your manufacturing licence, but the class is what decides it. Sending a Class A application to CDSCO centrally is a common way to lose a fortnight.
What you need before you apply
An FSC is granted against an existing licence, not instead of one. You must already hold a valid licence to manufacture for sale or for distribution of the device, with the product on the approved product list. If the device is not on that list, the FSC application cannot cover it — the licence has to be amended first. Getting that licence right is the CDSCO manufacturing licence work that precedes everything here.
Documents required
- Covering letter — signed and stamped by the authorised signatory.
- Proof of fee payment — the Bharatkosh challan receipt.
- Valid manufacturing licence — with the approved product list attached.
- Legal undertaking on ₹100 stamp paper — stating that no action has been initiated against you in respect of adverse events, market complaints or Not of Standard Quality (NSQ) reports.
The undertaking is the clause worth reading twice before signing. It is a declaration about your whole product portfolio, not only the device you are exporting.
The fee
₹1,000 per category of medical device, paid through Bharatkosh, with the challan receipt filed as part of the application. Per category, not per product — so grouping the list correctly before you pay is worth a few minutes.
How to apply
Applications are made online through the CDSCO Online System for Medical Devices at cdscomdonline.gov.in. The earlier hard-copy route described in older guidance has been superseded; if you are working from a guidance note that tells you to submit paper, you are reading a withdrawn version.
How long it takes
CDSCO does not publish a statutory processing timeline for a Free Sale Certificate, and neither the current guidance nor its predecessor states one. Treat any specific figure you find quoted online, including the thirty-working-day number that circulates widely, as unsourced. Plan your export schedule around the application being lodged correctly and completely, which is the variable you control.
Devices that are not notified
The FSC route described here is for regulated medical devices. CDSCO guidance directs manufacturers of non-notified products to the Directorate General of Foreign Trade for the equivalent export certification. Establishing which side of that line your product falls on is a classification question, and it is worth settling before you start an application that cannot be granted.
Where this goes wrong
Applying for a product that is not on the approved list. The licence may be valid and the device may be in production, but if it was never added to the approved product list the FSC cannot name it.
Signing the undertaking without checking. An open NSQ report or market complaint anywhere in the portfolio makes the declaration untrue. Check before signing, not after.
Paying per product instead of per category. Fees are set per category of device. A list grouped carelessly costs more than it needs to.
Assuming the FSC satisfies the importing country. It is one document in a registration dossier. Most regulators also want a certificate of conformity, a quality system certificate, or their own in-country registration. The FSC opens the file; it does not close it.
Frequently asked questions
What does FSC stand for?
Free Sale Certificate. In an export context it is also called a Certificate for Export, and some importing authorities refer to the same evidence as a Certificate of Free Sale.
Can we get an FSC without a manufacturing licence?
No. The certificate is issued to a manufacturer holding a valid licence to manufacture for sale or for distribution, and the device must appear on the approved product list attached to that licence.
Which authority do we apply to?
Class C and Class D devices go to the Central Licensing Authority. For Class A and Class B devices, CDSCO guidance directs manufacturers to their respective State Licensing Authority.
How much does a Free Sale Certificate cost?
₹1,000 per category of medical device, paid via Bharatkosh, with the challan receipt submitted as proof of payment.
Getting the application right first time
Most rejected FSC applications fail on the file rather than the facts: a product missing from the approved list, a challan that does not match the categories claimed, or an undertaking signed without checking the portfolio behind it. Medfins prepares and lodges Free Sale Certificate applications as part of our India regulatory services — send us your licence and product list and we will tell you what the application needs.
Source: CDSCO Guidance Document on Free Sale Certificate, CDSCO/MD/GD/FSC/01/2024.
