What is a Free Sale Certificate (FSC)?
A Free Sale Certificate (also referred to as a Certificate of Free Sale or Free Sale and Commerce Certificate - FSCC) is a vital statutory trade document issued by authorized government bodies in India—primarily the Directorate General of Foreign Trade (DGFT) under the Foreign Trade Policy, or the Central Drugs Standard Control Organisation (CDSCO) / State Food & Drug Administration (FDA) for medical devices and therapeutics.
Foreign national health authorities, customs administrations, and commercial buyers across the Middle East, Africa, ASEAN, Latin America, CIS, and Europe mandate an FSC prior to registering or clearing imported consignments. The certificate provides sovereign assurance that the specified goods are freely marketed, legally manufactured, and distributed for domestic consumption throughout the Republic of India without health or safety prohibitions.
Product Categories Requiring Free Sale Certificates
Consumer & Industrial Goods
Items not regulated under the Drugs & Cosmetics Act—such as engineering items, fitness equipment, non-medicated cosmetics, textiles, plastics, chemicals, and industrial consumables. Issued by Regional Authorities of DGFT.
Medical Devices & Diagnostics
Class A, B, C, and D medical devices, in-vitro diagnostics (IVDs), surgical equipment, and health devices regulated under the Medical Device Rules, 2017. Issued by CDSCO or State Licensing Authorities (SLA).
Eligibility & Documentation Checklist
To obtain an FSC without rejection or regulatory audits, exporters must submit a verified evidence file. Ocean Technovative assists in preparing and compiling all statutory exhibits:
- Valid IEC & RCMC: Active Importer-Exporter Code linked with DGFT portal and relevant Export Promotion Council (EEPC, Pharmexcil, Chemexcil, etc.) membership.
- Manufacturing License / Factory Registration: Valid state manufacturing license, DIC industrial registration, or Udyam certificate demonstrating authorized production premises.
- Proof of Domestic Sale: Copies of domestic tax invoices, e-way bills, and commercial contracts proving genuine commercial sale within India.
- Quality Standards Certification: ISO 13485 (for medical devices), ISO 9001, WHO-GMP, or BIS certification establishing compliance with Indian and international standards.
- List of Products with HS Codes: Exhaustive schedule of product variants, brand names, model numbers, intended use, and 8-digit ITC (HS) classifications.
Procedural Timeline & Embassy Attestation Support
End-to-End Issuance Pipeline
Ocean Technovative manages the complete digital application on the DGFT / CDSCO portal using verified Class 3 / DGFT Digital Signature Certificates. The typical issuance timeline is 3 to 7 working days upon file verification.
Apostille & Embassy Legalization: For countries that are parties to the Hague Apostille Convention or require bilateral consular legalization (e.g., UAE, Saudi Arabia, Kuwait, Egypt, Vietnam), we coordinate Ministry of External Affairs (MEA) apostille and respective embassy attestation.