An export order is close. The distributor abroad has asked for one document before their regulator will even open the file: a Free Sale Certificate from India. The manufacturer applies, and the application comes back — the product list includes a model built only for export, or the undertaking was notarised months ago, or it went to the wrong licensing authority.
A Free Sale Certificate (FSC) is a short document with a narrow purpose. It tells a foreign regulator or buyer that the device is licensed and freely sold in its country of origin. For Indian manufacturers, CDSCO sets out exactly how to obtain one, and almost every delay comes from not reading those conditions closely. This guide walks through who can apply, where, with what, and where applications go wrong.
What an Indian FSC certifies, and what it does not
CDSCO’s guidance document for obtaining a Free Sale Certificate for licensed medical devices in India (Doc. No. CDSCO/MD/GD/FSC/02/2024) is written for one audience: Indian medical device manufacturers that hold a valid manufacturing licence and intend to export. The certificate is issued for export purposes, against products covered by that licence.
Two limits follow directly from the guidance.
- No licence, no FSC. The application rests on a copy of the valid manufacturing licence. A device that is not on your licence cannot be on your certificate.
- No FSC for export-only products. The guidance states that an FSC may not be granted for products meant exclusively for export, and applicants must keep such products off the application. The certificate attests to free sale in India; a product that is not sold in India cannot have it.
It is also worth being clear about what the FSC is not. CDSCO’s FAQ on the Medical Devices Rules confirms that a WHO GMP certificate is not issued for medical devices; where an export market asks for a certificate of that kind, the licensing authority may consider issuing the necessary certificate under the Medical Devices Rules, 2017 instead.
Which authority issues it
CDSCO’s FAQ answers this in one line: the licensing authority that issued the licence may issue certificates such as the Non-Conviction Certificate, Free Sale Certificate and Market Standing Certificate. The FSC guidance applies it by device class:
- Class A and Class B devices — apply to the State Licensing Authority.
- Class C and Class D devices — apply to the Central Licensing Authority.
The FAQ confirms specifically that for Class A non-sterile, non-measuring devices, the applicant approaches the concerned State Licensing Authority for these certificates.
A manufacturer with a mixed portfolio — say Class B consumables made under a state licence and a Class C device under a central licence — therefore makes two separate applications to two different authorities. Treating it as one application is the first mistake to avoid.
Where to apply
Applications are made online only, through the Medical Devices online portal at cdscomdonline.gov.in. CDSCO’s FAQ states that applicants may submit all such applications online through the portal to the concerned licensing authority, and the FSC guidance makes online submission the only mode.
The documents CDSCO asks for
CDSCO’s checklist for the grant of a Free Sale Certificate for medical devices, and Section 4 of the guidance, list five items:
- Covering letter stating the intent of the application and listing the enclosed documents, signed and stamped by an authorised signatory with name, designation and firm details.
- The system-generated application from the portal, showing the licence number and the list of products for which the FSC is requested.
- Fee challan receipt. The guidance states the fee under the Second Schedule of the Medical Devices Rules, 2017 as INR 1,000 per category of medical device, paid online through Bharatkosh.
- A copy of the valid manufacturing licence, issued by the Central or State Licensing Authority, along with the retention application file number for all applied products where applicable.
- A legal undertaking from the manufacturer on a Rs. 100 registered stamp paper, recently notarised, stating that no action has been initiated against the manufacturer, and that it has not been convicted, due to adverse events, market complaints or Not of Standard Quality (NSQ) reports for the applied products.
The undertaking format in Annexure A of the guidance carries the firm’s details, the licence number and date, and a product list giving the generic name, brand name and model number of each device, with the declaration made as of the date of the undertaking.
For in vitro diagnostics, CDSCO publishes a separate checklist for the grant of an FSC for IVDs. It lists a covering letter, the notarised legal undertaking, a copy of the relevant import or manufacturing licence, the fee challan and the application, with any other documents if required.
How long the certificate lasts
CDSCO’s FAQ states that a Free Sale Certificate issued by the licensing authority is valid up to the validity of the manufacturing licence. The FSC guidance adds the condition that matters in practice: validity runs to the end of the manufacturing licence provided the licensing authority has not initiated regulatory action on the applied products.
Compare that with the Market Standing Certificate, which the same FAQ says is valid for one year from the date of issue. Manufacturers who request both for the same tender should diary the MSC separately.
Neither the guidance nor the FAQ sets a processing timeline for issuing the FSC. Plan the application well ahead of the date your foreign distributor needs the document, particularly if the certificate must then be legalised or apostilled for the destination country.
Export-only products: the neutral code route
Many Indian manufacturers make some products only for export — a private-label model for an overseas brand, or a variant that is not marketed in India. These cannot go on an FSC, but they are not outside the system either.
CDSCO’s FAQ says that where an applicant intends to manufacture only for export, “For Export only” should be written under the generic name in the application form. It also states that the Central Licensing Authority approves the neutral code or special code number for export purposes, for all classes of medical device.
The practical consequence: decide at licensing stage which products will be sold in India and which are for export only. That decision governs which ones can later carry an FSC.
Where this goes wrong
Export-only products on the application. The guidance is explicit that products meant exclusively for export must be kept off the FSC application. Including one invites a query or rejection and delays the products that were eligible.
The wrong authority. Class A and B devices go to the State Licensing Authority and Class C and D to the Central Licensing Authority. A single application covering both, or one sent to the authority that did not issue the licence, comes back.
A stale undertaking. The checklist asks for an undertaking that is recently notarised, and the declaration speaks as of its date. An undertaking notarised for an earlier application and reused months later invites a query.
Product names that do not match. The undertaking lists generic name, brand name and model number. If these differ from the licence, or from the product names in the destination country’s dossier, the certificate may be correct and still useless to the importer abroad. Settle the exact product list with your distributor before you apply.
Retention status not in order. The checklist asks for the retention application file number for applied products where applicable. If the licence retention is not current, the licence the FSC relies on is in question.
Forgetting the condition on validity. The FSC lasts as long as the manufacturing licence only while no regulatory action has been initiated on the products. Adverse event action, market complaints or an NSQ report on a listed product can undermine both the certificate and the undertaking behind any future application.
Frequently asked questions
Can a contract manufacturer get an FSC for products it makes for an overseas brand?
Only for products covered by its manufacturing licence and sold in India. CDSCO’s guidance excludes products meant exclusively for export. Products made only for an overseas brand are handled under the “For Export only” and neutral code arrangements instead.
Is a Free Sale Certificate the same as a Market Standing Certificate?
No. Both are issued by the licensing authority that issued your licence, but CDSCO’s FAQ gives them different validity: the FSC lasts up to the validity of the manufacturing licence, while the Market Standing Certificate is valid for one year from issue.
Who issues the FSC for a Class B device?
The State Licensing Authority. Under CDSCO’s guidance, Class A and B devices go to the State Licensing Authority and Class C and D devices to the Central Licensing Authority, through cdscomdonline.gov.in in both cases.
How much does a Free Sale Certificate cost?
CDSCO’s guidance states the government fee as INR 1,000 per category of medical device, paid online through Bharatkosh. Notarisation, and any legalisation required by the destination country, are separate.
Does the FSC need renewing?
Not on a fixed cycle. CDSCO’s FAQ ties its validity to the manufacturing licence, and the guidance makes that conditional on no regulatory action having been initiated on the applied products. Many buyers abroad nonetheless ask for a recently issued certificate, so check what your distributor’s regulator expects.
We are an importer. Can we get an Indian FSC for imported devices?
The medical device FSC guidance is written for Indian manufacturers holding a manufacturing licence. CDSCO’s IVD checklist refers to a copy of the respective import or manufacturing licence, so the position may differ for IVDs. Ask your licensing authority before applying.
Medfins prepares FSC applications alongside CDSCO manufacturing licences, and plans export-only products at licensing stage so that the certificates your distributors need are available when they need them. Contact our team with your licence number, device list and destination markets, or see our CDSCO registration and licensing service.
