FREE SALE CERTIFICATE
Free Sale Certificate for Medical Devices in India
A Free Sale Certificate (FSC) is an important regulatory
document for Indian medical device manufacturers who intend
to export their products to international markets.
The FSC is issued by the applicable Licensing Authority
based on the manufacturer's valid medical device
manufacturing licence and the applicable regulatory
requirements under the Medical Devices Rules, 2017.
At MDR Consultants, we assist manufacturers in assessing
FSC eligibility, preparing the required documentation,
submitting the application and responding to regulatory
requirements during the process.
FSC & Medical Device Export
01
Applicable to licensed Indian medical device manufacturers
seeking an FSC for export purposes.
02
Application authority depends on the device class and
applicable licensing arrangement.
03
Application and supporting documents are submitted through
the applicable online system.
FSC OVERVIEW
What is a Free Sale Certificate?
A Free Sale Certificate (FSC) is a regulatory certificate used
for export purposes to support confirmation that specified
medical devices are licensed for sale or distribution in India,
subject to the applicable regulatory requirements.
Under the CDSCO Guidance Document on Free Sale Certificate,
Indian medical device manufacturers holding a valid manufacturing
licence may apply for an FSC for export of their medical devices.
The FSC can support overseas regulatory submissions, distributor
requirements, tenders and other market-entry documentation where
a Free Sale Certificate is requested by the importing country or
relevant authority.
CDSCO REQUIREMENTS
Key Regulatory Points for FSC
01
Valid Manufacturing Licence
The applicant should hold a valid licence to manufacture
medical devices for sale or distribution under the
Medical Devices Rules, 2017.
02
Applicable Licensing Authority
For Class C and Class D devices, the application is made
to the Central Licensing Authority. For Class A and
Class B devices, the application is made to the State
Licensing Authority.
03
Online Application
The CDSCO 2024 guidance provides for online submission
through the applicable medical device online system.
04
Product List
The FSC application should identify the medical devices
for which the certificate is being requested, consistent
with the applicable manufacturing licence.
05
Applicable Government Fee
The prescribed FSC fee is paid through the online
Bharatkosh challan at the rate specified in the
applicable CDSCO guidance.
06
Legal Undertaking
The manufacturer is required to provide the prescribed
legal undertaking relating to adverse events, market
complaints and Not of Standard Quality reports.
ELIGIBILITY
Who Can Apply for an FSC?
Indian Medical Device Manufacturer
The applicant should be an Indian medical device
manufacturer with a valid manufacturing licence
for sale or distribution.
Licensed Products
The products included in the FSC application should
be appropriately covered under the applicable
manufacturing licence.
Export Requirement
The FSC should be required for an export-related
regulatory or commercial purpose.
Important CDSCO Condition
Products intended exclusively for export should
not be included in the FSC application.
APPLICATION PROCESS
How to Obtain a Free Sale Certificate?
01
Eligibility Assessment
We review your manufacturing licence, product details
and device classification to assess the applicability
of an FSC.
02
Product Verification
We verify the products proposed for the FSC against the
applicable manufacturing licence and approved product
details.
03
Document Preparation
We prepare and organize the covering letter, application
details, licence documents, undertaking and other
applicable supporting records.
04
Online Application
The FSC application is submitted through the applicable
CDSCO medical device online system with the required
information.
05
Fee Submission
The applicable government fee is paid through the
prescribed online Bharatkosh challan process.
06
Regulatory Processing
The application and submitted documents are processed
by the applicable Licensing Authority in accordance
with the applicable regulatory requirements.
07
Query Management
Where clarification or additional information is
requested, we assist in preparing and coordinating
the required response.
08
FSC Issuance
Once the applicable requirements are fulfilled, the
Licensing Authority issues the Free Sale Certificate
for the applicable products.
DOCUMENTATION
Documents Generally Required for FSC
01
Covering Letter
A signed and stamped covering letter clearly
stating the purpose of the FSC application and
relevant submission details.
02
FSC Application
The applicable application generated or completed
through the medical device online system.
03
Fee Challan Receipt
Proof of payment of the prescribed FSC fee through
the applicable Bharatkosh process.
04
Valid Manufacturing Licence
A valid copy of the manufacturing licence issued
by the applicable State or Central Licensing
Authority.
05
Product Details
Details of the medical devices for which the FSC
is requested, as applicable to the manufacturing
licence.
06
Legal Undertaking
The prescribed undertaking on a Rs. 100 registered
notarized stamp confirming the required regulatory
declarations.
EXPORT SUPPORT
Why is an FSC Important for Medical Device Export?
✓
Support Overseas Regulatory Submissions
An FSC may be requested by an overseas regulatory
authority as part of the documentation required
for registration or market entry.
✓
Support Distributor Requirements
Importers, distributors or business partners in
certain markets may request an FSC as supporting
evidence for their regulatory or commercial
processes.
✓
Support International Market Entry
Where required by the destination market, the FSC
can form part of the regulatory documentation
submitted for market access.
✓
Demonstrate Indian Licensing Status
The FSC is linked to the applicable Indian
manufacturing licence and the products covered
by the certificate.
IMPORTANT COMPLIANCE NOTE
Important FSC Compliance Points
Valid Manufacturing Licence
The applicant must have a valid manufacturing
licence for sale or distribution of the
applicable medical devices.
Product Eligibility
Products included in the application should
be appropriately covered under the applicable
manufacturing licence.
Exclusively Export Products
CDSCO's 2024 FSC guidance states that FSC may
not be granted for products meant exclusively
for export. Such products should therefore not
be included in the FSC application.
FSC Validity
The FSC is stated to remain valid up to the
validity of the manufacturing licence, provided
that no regulatory action has been initiated
by the Licensing Authority on the applied
products.
OUR SERVICES
How MDR Consultants Can Help
At MDR Consultants, we provide end-to-end regulatory
assistance for Free Sale Certificate applications for
Indian medical device manufacturers.
FSC applicability assessment
Manufacturing licence verification
Product list review and preparation
FSC documentation and application preparation
Online submission assistance
Bharatkosh fee documentation support
Legal undertaking coordination
Regulatory query response assistance
Application follow-up support
Export documentation coordination
WHY MDR CONSULTANTS
Why Choose MDR Consultants for FSC Assistance?
Medical Device Regulatory Focus
We focus on medical device regulatory requirements
and structure the FSC process around the applicable
CDSCO framework.
Licence-Based Assessment
We review the manufacturing licence and product
coverage before proceeding with the FSC application.
Documentation Support
We help organize the application documents and
supporting records required for submission.
Regulatory Query Assistance
If the authority raises a query, our team assists
with preparing the appropriate regulatory response.
Export-Oriented Support
We help manufacturers prepare FSC documentation
with their intended international market requirements
in mind.
End-to-End Coordination
From initial eligibility review to submission and
follow-up, we support the FSC process at each stage.
Planning to Export Your Medical Devices?
Let MDR Consultants assist you with FSC eligibility assessment,
documentation, online application support and regulatory
coordination so you can prepare your medical device export
documentation with greater confidence.
