Documents needed for Loan License for Medical Devices
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Documents needed for a Loan License for Medical Devices - Process, Fees, Benefits
The Central Drugs Standard Control Organisation (CDSCO) is India’s National Regulatory Authority and a highly influential organization in the country. It operates under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Within the CDSCO, the Drug Controller General of India (DCGI) oversees pharmaceuticals and medical devices. The CDSCO is responsible for approving new drugs and issuing licenses under the Drugs and Cosmetics Rules of 1945.
What is a CDSCO Loan License for Medical Devices?
CDSCO Loan License is an agreement between two Individuals who have been granted the rights by the licensing authority to the applicant who does not have a production facility or any other arrangements for production but can use other’s facilities and infrastructure for manufacturing the device with the mutual consent of Individuals involved.
What Documents are required in the CDSCO Loan License process?
Documents required in the process are as follows:
- Cover Letter
- TR6 Challan
- All Applicable Statutory Forms
- Required Fees of applicable Statutory Forms
- A Notary with the name, address, and other necessary details of the required personnel involved in daily affairs of the Company along with the respective conduct of business with a photograph needs to be attested
- Proof of Residential Address (Ration Card/Passport/Aadhaar Card)
- A Consent Letter (declaring all the available facilities and the license details in possession that indicates all the categories of drugs and the number of CDSCO Loan License already issued for the Company)
- Declaration of the technical personnel involved in the production process for analysis
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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