Free Sale Certificate For Medical Devices
Get Your Free Sale Certificate For Medical Devices in India
Medical Device FSC Certification
Get Your Free Sale Certificate For Medical Devices in India
A Free Sale Certificate For Medical Devices is a mandatory document required for exporting medical devices from India to various global markets. Issued by the Central Drugs Standard Control Organization (CDSCO), it confirms that the product is legally manufactured and sold in the domestic market. This certification validates that the medical device complies with Indian regulatory standards and is eligible for export.
At AccordMed, we offer complete assistance for obtaining the Medical Device FSC Certification, ensuring smooth and compliant processing in line with CDSCO requirements.
What is a Free Sale Certificate For Medical Devices?
The Free Sale Certificate For Medical Devices, also known as a Certificate for Export, serves as proof that a product is freely sold and approved in India. It is crucial for manufacturers looking to enter international markets. CDSCO issues this certificate only to manufacturers who hold a valid medical device manufacturing license in India.
Who Can Apply?
Only licensed manufacturers of medical devices in India are eligible to apply for the Free Sale Certificate For Medical Devices. The manufacturer must possess a valid license under the Medical Device Rules issued by CDSCO. The certificate confirms that the product is approved for domestic sale and meets quality and safety standards.
Step-by-Step Application Process
To obtain the Medical Device FSC Certification, applicants must follow the steps below:
- Register on the CDSCO Sugam online portal
- Fill the application form for FSC in the approved format
- Upload all required documents per the official checklist
- Submit a government fee of ₹1,000 per device
- Submit the application online and await CDSCO approval
Medical Device Registration Services CDSCO
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Documents Required
To apply for the Free Sale Certificate For Medical Devices, the following documents must be submitted:
- Cover letter on the manufacturer’s letterhead with seal and signature
- Rs. 100 notarized undertaking stating there are no complaints or adverse events
- Copy of valid manufacturing license with the list of approved products
- Export product list in Word format
Validity and Processing Time
- Government Fee: ₹1,000 per device
- Validity: Same as the validity of the manufacturing license
- Timeline: CDSCO typically processes the Medical Device FSC Certification within 30 working days
Important Points to Note
- FSC is issued only for notified medical devices registered with CDSCO
- The manufacturing site must have a valid license and a clean market record
- All documents should comply with the official checklist
- The undertaking must be submitted on stamped and notarized paper
Why Choose us ?
AccordMed simplifies the process of obtaining the Free Sale Certificate For Medical Devices and provides expert regulatory support from start to finish. Our experienced team ensures your documentation, submission, and communication with CDSCO are handled with precision to avoid delays or rejections.
Whether you’re an Indian manufacturer or an authorized agent, we help you navigate every step to successfully obtain your Medical Device FSC Certification.
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