- An official document issued by the Central Licensing Authorities or State Licensing Authorities that certifies a medical device is manufactured in India and freely sold in the domestic market with regulatory approval.
- Also known as a “Certificate for Export”, it’s often a requirement for manufacturers looking to export medical devices from India.
Why is a Free Sale Certificate Important?
- Proof of Regulatory Compliance: The FSC demonstrates to foreign regulatory bodies that the medical device meets Indian regulatory standards and has undergone approval processes.
- Market Access: Many countries require an FSC as part of their import regulations for medical devices. It facilitates registration and market entry into the foreign market.
- Trust and Credibility: An FSC enhances the product’s credibility and indicates the manufacturer’s commitment to quality and safety standards.
How to Obtain a Free Sale Certificate from CDSCO
- Online Application:
- Register on Medical Device online portal
- Draft your FSC application, including all required documents.
- Submit the application through the Online Medical Devices portal (https://cdscomdonline.gov.in).
- Required Documents:
- Covering letter explaining the purpose of the application.
- Valid manufacturing license for Medical Devices (from the State Licensing Authority or Central Licensing Authority).
- List of products for which you need the FSC.
- An undertaking stating no pending actions against you related to market complaints, adverse events, or Not of Standard Quality (NSQ) reports on any product.
- Processing:
- The appropriate licensing authority (determined by where you are licensed) will review your application.
- The CDSCO aims to issue the FSC within 30 working days.
Important Things to Note:
- Eligible Devices: The FSC process is primarily for notified medical devices (regulated products).
- State vs. Central Authority: The issuing authority (State Licensing Authority or Central Licensing Authority) will be the one that granted your manufacturing license.
- Validity: In the past, FSCs often aligned with the validity of the manufacturing license.
Additional Resources:
- CDSCO Guidance Document on Free Sale Certificates: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/GuidanceFreeSalecertificate.pdf
- CDSCO Medical Devices Online Portal: https://cdscomdonline.gov.in