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Medical Device Services

Quick Snapshot

  • Service / Form: Free Sale Certificate
  • Who Can Apply: Manufacturer exporters or merchant exporters may benefit from the Free Sale and Commerce Certificate.
  • Timeline: Generally within 30 working days, subject to completeness of application, document verification, and authority processing timelines.
  • Fee: Applicant shall make a payment of ₹1000 for obtaining Free Sale Certificate.

What is Free Sale Certificate?

A Free Sale and Commerce Certificate is a certificate issued for export of any other item which is not restricted or prohibited for export confirming that the product is freely sold in the country but without any indication that the product is evaluated for safety and efficacy and is registered for use in the country. It gives an assurance from a foreign agency that the products listed on the certificate are freely sold and manufactured in the country seeking to export a particular item.

When Do You Need FSC Support?

Support for preparing, reviewing, and coordinating Free Sale Certificates (FSCs) for medical device import, registration, export, and international market access.

When Do You Need FSC Support?
  • Import of medical devices into India under CDSCO regulations
  • Registration of medical devices in foreign countries
  • Appointment of an Authorized Agent or regulatory representative for market-entry requirements
  • Participation in international government or private tenders
  • Customs clearance and export documentation
  • Distributor onboarding and market expansion
  • Regulatory submissions for Class A, B, C, and D medical devices
  • Proof of legal marketing status in the country of origin
  • Submission along with CE certificate, ISO 13485, or technical documentation
Key Challenges
  • Difficulty obtaining an FSC from the competent authority
  • Country-specific legalization, notarization, or apostille requirements
  • Mismatch between FSC and other regulatory document details
  • Expired, incomplete, or incorrectly issued certificates causing regulatory delays
  • Incorrect manufacturer or Authorized Representative information
  • Delays due to translation and embassy authentication
  • Varying FSC acceptance criteria across countries
  • Coordination challenges among manufacturers, importers, and regulators
  • Inconsistencies between FSC, CE certificates, ISO certificates, and labelling documents

Our Approach and What You Will Get

End-to-end support for FSC assessment, documentation, authentication, regulatory submissions, and international market access.

Our Approach
  • Assess FSC requirements based on device classification and target market
  • Evaluate import/export regulatory requirements for medical devices
  • Review manufacturer documents and identify documentation gaps
  • Verify product, license, and market alignment for FSC applications
  • Provide guidance on obtaining the correct FSC format from the competent authority
  • Support preparation, review, and compilation of regulatory documentation
  • Assist with notarization, legalization, and apostille processes
  • Coordinate document authentication for international submissions
  • Ensure alignment of FSC details with technical files and regulatory records
  • Help minimize submission delays, deficiencies, and compliance issues
  • Manage end-to-end regulatory coordination for smoother FSC documentation
What You Will Get (Deliverables)
  • Assessment of FSC documentation
  • Regulatory consultancy on FSC requirements
  • Review of manufacturer and product information
  • Guidance on notarization, apostille, and legalization needs
  • Checklist preparation for supporting documents
  • Verification of consistency across regulatory documents
  • Compliance assistance for regulatory submissions, including CDSCO requirements
  • Coordination of import/export documentation
  • Gap analysis and support for resolving deficiencies
  • Consultation on country-specific FSC acceptance criteria
Free Sale Certificate Support

Why Choose Tacit Medtek and Case Example

Comprehensive support for FSC documentation, international compliance, legalization, and medical device import registration.

Why Choose Tacit Medtek
  • Expertise in medical device regulatory compliance
  • Experience with CDSCO and international documentation standards
  • Comprehensive support for import and export regulatory processes
  • Structured review of regulatory documentation
  • Assistance for Class A, B, C, and D medical devices
  • Coordination of legalization and apostille procedures
  • Timely regulatory guidance and compliance monitoring
  • Professional support for startups, manufacturers, importers, and distributors
  • In-depth knowledge of MDR 2017 documentation requirements
Case Example
  • Challenge: A foreign medical device manufacturer exporting to India faced delays because the regulatory authority required a valid Free Sale Certificate consistent with the product portfolio and compliance documents. The submitted FSC contained discrepancies in device names and manufacturer details compared with other regulatory records.
  • Our Approach: Tacit Medtek reviewed the submitted documents, identified inconsistencies, and guided the client in obtaining a revised FSC from the competent authority. The team verified alignment with ISO 13485 and product documentation and supported the legalization and compliance review process before regulatory submission.
  • Outcome: The client successfully obtained a compliant FSC package aligned with applicable regulatory submission requirements, reducing documentation deficiencies and supporting smoother progress in the import registration process.

FAQ

Frequently Asked Questions

01
If my IEC is in DEL/cancelled/suspended, am I eligible to apply for Free Sale and Commerce Certificate?

If your IEC is suspended/cancelled/in DEL, you shall not be allowed to proceed with submission of your request for the issuance of a Free Sale and Commerce Certificate.

02
What items are allowed for export under the Free Sale and Commerce Certificate?

Free Sale and Commerce Certificate may be issued for exports as under:

  • For items not covered under the Drugs and Cosmetics Act, 1940, which have usage in hospitals, nursing homes and clinics for medical and surgical purposes and are not prohibited for export.
  • Any item that is not restricted or prohibited for export.
03
What is an application number? Where can I find it?

When an application is created and saved for the first time, an application number gets created. All draft applications have an application number. The same can be found by following the below path:

My Dashboard > Draft applications

04
Where can I view my approved Free Sale and Commerce Certificates?

Please follow the below path to get the approved Free Sale and Commerce Certificates:

  • My Dashboard > Submitted Applications
  • Enter Type of Scheme (select in dropdown: Certificate Management) and Type of Sub Scheme (Apply for Free Sale and Commerce Certificate)
  • Click on Search
  • Click on Action (under the Results) > View Approved Licenses > View Letter
05
What is view lifecycle? Where can I see it?

Please follow the below path to view the lifecycle of a submitted file for issuance of a Free Sale and Commerce Certificate:

  • My Dashboard > Submitted Applications
  • Enter Type of Scheme (select in dropdown: Certificate Management) and Type of Sub Scheme (Apply for Free Sale and Commerce Certificate)
  • Click on Search
  • Click on Action (under the Results) > View Life Cycle
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