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Free Sale Certificate (FSC)

What is an FSC?​

A Free Sale Certificate (FSC) — sometimes called a Certificate to Foreign Government (CFG) — is a document issued by the competent authority of the country of manufacture confirming that the medical device is legally manufactured and sold in that country.

Why is it required?​

CDSCO requires an FSC as evidence that the device has been authorised by the home country regulator before granting an Indian import licence. It serves as a proxy for a baseline level of regulatory scrutiny.

Accepted issuing authorities​

CDSCO accepts FSCs issued by:

  • USA — US FDA (Certificate to Foreign Government)
  • EU / EEA — Notified Body certificate and Declaration of Conformity (CE marking)
  • Australia — TGA (Certificate of Free Sale)
  • UK — MHRA (Certificate of Free Sale)
  • Canada — Health Canada (Medical Device Licence confirmation)
  • Japan — PMDA (Shonin / approval certificate)
  • Other countries — competent authority certificate acceptable to CDSCO

FSC content requirements​

The FSC should state:

  • Manufacturer name and address;
  • Device name and description;
  • That the device is legally sold in the issuing country;
  • Issuing authority name and official signature/stamp;
  • Date of issue (generally accepted within 3 years of issue).

Notarisation and apostille​

CDSCO may require the FSC to be apostilled or notarised by the Indian embassy / consulate in the country of issue. Requirements vary — confirm current requirements via the SUGAM checklist or CDSCO circular.