Indian medical device manufacturers seeking to export their products may be required by an overseas regulator, purchaser or importing authority to provide evidence that the devices are licensed for sale or distribution in India. In such cases, a Free Sale Certificate (FSC) may serve as an important export-supporting regulatory document.
For medical devices regulated under the Medical Devices Rules, 2017 (MDR 2017), the Central Drugs Standard Control Organization (CDSCO) has issued specific guidance describing the procedure for obtaining an FSC from the applicable Licensing Authority.
The current CDSCO guidance is “Guidance Document for obtaining Free Sale Certificate (FSC) for licensed medical devices in India,” Document No. CDSCO/MD/GD/FSC/02/2024. The guidance states that the FSC application is intended for Indian manufacturers holding a valid manufacturing licence and seeking the certificate for export purposes.
A Free Sale Certificate is a certificate issued by the applicable Licensing Authority for export purposes in relation to medical devices that are licensed for sale or distribution in India under the Medical Devices Rules, 2017.
The FSC should not be interpreted as a separate product approval or as an independent certification that the device has actually been commercially sold in India. Rather, the certificate is connected to the manufacturer's valid manufacturing licence and the products covered by that licence.
The CDSCO guidance specifically states that an FSC application may be made by Indian medical device manufacturers having a valid manufacturing licence and intending to obtain the certificate for export of medical devices.
The applicable Licensing Authority depends on the risk classification of the medical device.
|
Medical device class |
Authority for FSC application |
|
Class A |
State Licensing Authority (SLA) |
|
Class B |
State Licensing Authority (SLA) |
|
Class C |
Central Licensing Authority (CLA) |
|
Class D |
Central Licensing Authority (CLA) |
For Class C and Class D medical devices, the application is made to the Central Licensing Authority. For Class A and Class B devices, the application is made to the respective State Licensing Authority. This allocation is also reflected in the 2019 amendment to Rule 91 of the Medical Devices Rules, 2017.
The CDSCO FSC guidance applies to Indian medical device manufacturers that:
The products included in the FSC application should correspond with the products covered by the applicable manufacturing licence.
No.
The CDSCO guidance specifically states that an FSC may not be granted for products intended exclusively for export purposes. Manufacturers should therefore ensure that products manufactured only for export are not included in an FSC application.
This distinction is important. An FSC application concerns licensed medical devices covered by a manufacturing licence for sale or distribution under MDR 2017; it should not be used to establish domestic sale authorization for a product that is manufactured exclusively for export.
The current CDSCO guidance identifies the following documents for an FSC application:
The covering letter should clearly state the purpose of the application. It may also include the list of documents being submitted and other relevant information.
The letter should be signed and stamped by the authorized signatory and should identify the signatory's name and designation as well as the firm's name and address.
The application form generated through the online system should contain the relevant manufacturing licence number and the product list for which the FSC is being requested.
This is an important point that should not be omitted from an FSC compliance checklist.
The prescribed FSC fee is payable through the online Bharatkosh challan.
The CDSCO guidance specifies a fee of ₹1,000 per category of medical device.
The fee provision is associated with the Second Schedule of the Medical Devices Rules, 2017, as amended by G.S.R. 318(E) dated 18 April 2019. That amendment also specifies that the relevant FSC applications are made to the CLA for Class C/D devices and the SLA for Class A/B devices.
The applicant must provide a valid copy of the licence to manufacture the relevant medical devices for sale or distribution.
The licence should be issued by the applicable Central or State Licensing Authority, depending upon the device classification.
The CDSCO checklist additionally refers to the retention application file number for all applied products, where applicable.
The manufacturer must submit a legal undertaking on a ₹100 registered, notarized stamp, recently notarized, in the prescribed format.
The undertaking covers the products for which the FSC is being requested and states that, as of the date of the undertaking, no action has been initiated against the manufacturer or conviction occurred due to adverse events, market complaints or Not of Standard Quality (NSQ) reports concerning the relevant products.
The CDSCO-prescribed undertaking also requires identification of the products, including details such as generic name, brand name and model number, with a separately notarized product list permitted where the number of products is larger.
The CDSCO guidance specifies online submission through the medical-device online system.
A manufacturer should generally proceed as follows:
Step 1 — Confirm the applicable authority
Determine whether the device falls under Class A/B or Class C/D and identify the corresponding SLA or CLA.
Step 2 — Verify the manufacturing licence
Confirm that the manufacturing licence is valid and that the devices proposed for the FSC are covered by the licence for sale or distribution.
Step 3 — Prepare the product list
Ensure that the product names, brand names and model numbers in the application and undertaking correspond with the licensed products.
Step 4 — Prepare the covering letter
The covering letter should identify the purpose of the FSC application and provide the required applicant and authorized-signatory details.
Step 5 — Generate the online FSC application
The system-generated application should reflect the applicable manufacturing licence number and product list.
Step 6 — Pay the prescribed fee
Pay the FSC fee through Bharatkosh at the applicable rate of ₹1,000 per category of medical device.
Step 7 — Prepare the legal undertaking
Prepare the prescribed ₹100 notarized undertaking and ensure that the declaration accurately reflects the regulatory status of the products included in the application.
Step 8 — Submit the application online
Upload the required documents and submit the application through the applicable online system.
Step 9 — Respond to regulatory queries, if raised
The manufacturer should promptly address any deficiency or clarification requested by the Licensing Authority.
The validity of the FSC is linked to the validity of the underlying manufacturing licence.
The CDSCO guidance states that the FSC remains valid up to the validity of the manufacturing licence, provided that no regulatory action has been initiated by the Licensing Authority against the products covered by the application.
Accordingly, manufacturers should monitor the status of the underlying manufacturing licence and the regulatory status of the products covered by the FSC.
Before submitting an FSC application, manufacturers should verify the following:
An FSC should not automatically be treated as a universal export authorization.
The importing country's regulatory authority may require additional documents, such as certificates concerning quality, manufacturing status, conformity, product registration or other regulatory evidence. The exact requirements depend upon the destination country and the type of medical device.
Therefore, manufacturers should verify the requirements of the importing country in addition to complying with the CDSCO FSC procedure.
The CDSCO FSC guidance identifies the following principal regulatory references:
Medical Devices Rules, 2017 — G.S.R. 78(E), dated 31 January 2017
The MDR 2017 framework regulates, among other matters, the manufacture, import, sale and distribution of medical devices in India. CDSCO identifies G.S.R. 78(E) dated 31 January 2017 as the notification through which the Medical Devices Rules, 2017 were published.
G.S.R. 318(E), dated 18 April 2019
This amendment modified Rule 91 and the Second Schedule in relation to the FSC framework, including the distinction between the Central Licensing Authority for Class C/D devices and the State Licensing Authority for Class A/B devices and the applicable fee provision.
CDSCO Guidance Document — CDSCO/MD/GD/FSC/02/2024
This is the principal CDSCO guidance document specifically addressing the procedure for obtaining an FSC for licensed medical devices in India.
For Indian medical device manufacturers, the Free Sale Certificate is an important export-related regulatory document where evidence of Indian authorization is required by an overseas authority or purchaser.
The current CDSCO guidance makes the basic requirements clear: the manufacturer should hold a valid manufacturing licence for sale or distribution, apply to the Licensing Authority appropriate to the device classification, submit the prescribed documents and fee, and provide the required legal undertaking.
Particular attention should be given to product-list accuracy, licence validity, the prescribed undertaking and the exclusion of products intended exclusively for export.
Because CDSCO requirements, online procedures and regulatory notices can change, manufacturers should verify the latest applicable CDSCO requirements before submitting an application.
Last Updated : 10 Sep 2026
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