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Free Sale Certificate from CDSCO for regulated Medical Devices Overview
- A certificate for export, commonly referred to as a free sale certificate, is an official document provided by the national regulatory authority.
- In India, the Central Drugs Standards Control Organization (CDSCO) simplifies the application procedure for obtaining a free sale certificate for medical devices that have been notified.
- Manufacturers can apply for a Free Sale Certificate for their regulated or notified medical devices through the online medical device portal, and CDSCO will issue the certificate within 30 working days.
- Manufacturers can apply for a Free Sale Certificate for their regulated or notified medical devices through the online medical device portal, and CDSCO will issue the certificate within 30 working days.
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Who Can Apply?
- Manufacturers with a valid manufacturing license are eligible to request a Free Sale Certificate from CDSCO.
Vital documentation
- The cover letter, bearing the applicant's name and address on official letterhead, has been properly signed and stamped by the organization's leader.
- A notarized stamp paper undertaking worth Rs.100 (With no market complaint or adverse event).
- A document in Word format that includes a compilation of products that necessitate a free sale.
- An authorized license for manufacturing, along with a comprehensive inventory of endorsed products.
Important Guidelines
- Obtaining FSC from CDSCO necessitates a valid manufacturing license, which is the foremost essential requirement.
- It is necessary to have a Legal Undertaking on a 100Rs stamp paper in order to protect against any market complaints and adverse events.
- The government fee that is relevant must be paid.
- In order to be eligible for FSC certification from CDSCO, products must belong to the specified categories.
- A manufacturer whose products have not received any complaints can readily acquire the FSC from CDSCO.
FAQ
How can I check the status of my Free Sale Certificate application from CDSCO for regulated Medical Devices?
You can check the status of your Free Sale Certificate application from CDSCO for regulated Medical Devices by contacting the CDSCO or checking online through their website.
What is a Free Sale Certificate from CDSCO for regulated Medical Devices?
A Free Sale Certificate from CDSCO for regulated Medical Devices is a document issued by the Central Drugs Standard Control Organization (CDSCO) in India, certifying that the medical device is freely sold in the country.
What is the difference between a Free Sale Certificate and a Certificate of Free Sale?
A Free Sale Certificate from CDSCO for regulated Medical Devices is specific to medical devices regulated by the CDSCO in India, while a Certificate of Free Sale is a more general document that may be issued by other regulatory authorities.
Can I apply for a Free Sale Certificate from CDSCO for regulated Medical Devices if my device is not manufactured in India?
Yes, you can apply for a Free Sale Certificate from CDSCO for regulated Medical Devices even if your device is not manufactured in India, as long as it meets the necessary requirements.
Are there any specific requirements for the packaging of medical devices with a Free Sale Certificate from CDSCO?
Yes, there may be specific requirements for the packaging of medical devices with a Free Sale Certificate from CDSCO for regulated Medical Devices, such as labeling and safety instructions.