If you’re an Indian medical device manufacturer looking to export your products, you’ll need a Free Sale Certificate (FSC). This certificate confirms that your medical devices are legally sold in India and meet regulatory requirements. Here’s a step-by-step guide to help you navigate the process.
Who Needs a Free Sale Certificate?
The FSC is essential for medical device manufacturers in India who already hold a valid manufacturing license and wish to export their products.
Where to Apply?
Applications must be submitted online through the CDSCO portal.
Steps to Obtain a Free Sale Certificate
- Submit an Application
The manufacturer must apply to the appropriate Licensing Authority (Central or State) based on the classification of the medical device under the Medical Devices Rules, 2017.
- Prepare a Covering Letter
Your application should include a covering letter detailing:
- The purpose of the application
- A list of submitted documents
- Any other relevant details
- The name, designation, and signature of the authorized signatory
- Pay the Required Fees
- The application fee is INR 1000 per category of medical device.
- Payments must be made through the Bharatkosh online system, and the challan receipt should be included with the application.
- Submit Supporting Documents
- A valid copy of the manufacturing license for sale/distribution of medical devices.
- An approved product list issued by the Licensing Authority (State or Central).
- Provide a Legal Undertaking
- A notarized undertaking on INR 100 non-judicial stamp paper.
- It should confirm that the manufacturer has no ongoing legal issues related to adverse events, market complaints, or quality concerns.
Important Notes
- Manufacturers of Class A and Class B medical devices should contact their respective State Licensing Authority for FSC issuance.
Regulatory References
- Medical Devices Rules, 2017 (G.S.R. 78(E), dated 31.01.2017)
- Government Gazette Notification (G.S.R. 318(E), dated 18.04.2019)
FAQs
What is the validity of Free Sale Certificate issued by the Licensing Authority?
Free Sale Certificate issued by the Licensing Authority is valid upto the validity of the manufacturing licence.
Who will issue the Free Sale Certificate/ Non-Conviction Certificate/ Market Standing Certificate in respect of Class A (non-sterile and non-measuring) medical device?
As the control of Class A medical devices is under the State Licensing Authority, therefore the applicant may approach to the concerned State Licensing Authority for obtaining such certificates.
How can Medfins help you?
Navigating regulatory requirements can be complex, and we can simplify the process for you. Our team can assist by:
- Ensuring Compliance: Reviewing your documentation to ensure it meets CDSCO requirements.
- Application Preparation: Drafting and submitting applications on your behalf.
- Legal and Technical Support: Assisting with legal undertakings and technical clarifications.
- Follow-ups with Authorities: Coordinating with the Licensing Authority for timely processing of your FSC.
- Ongoing Support: Providing guidance for future regulatory needs and market expansion.