Document Checklist for CDSCO Registration
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CDSCO Registration Document Checklist for Pre Screening of Application
CDSCO is the Central Drugs Standard Control Organisation being one of the most powerful organizations of India. CDSCO is India’s National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical & Medical Devices and its positioning with the Ministry of Health and Family Welfare. CDSCO is responsible for the approval of new drugs and granting of licenses under the Drugs and Cosmetics Rules, 1945.
Roles and Responsibilities of CDSCO
Central Drugs Standard Control Organisation is the National Regulatory Authority (NRA) of India. CDSCO is constantly thriving upon to bring out the transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of medical products which are being manufactured, import and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, Laying down the standards for Drugs, Control over the quality of Imported drugs in the country and coordination activities of state drug control organizations. CDSCO is also responsible for grant of licenses of certain specialized categories of critical Drugs such as Blood and Blood Products, I.V Fluids, Vaccine and Sera.
Licensing Authorities under CDSCO
There are 2 Licensing Authorities under Central Drugs Standard Control Organisation:
- State Licensing Authority (SLA): SLA is responsible for issuing the CDSCO manufacturing or wholesale license for the IVDs and Medical Devices that fall under class A & B.
- Central Licensing Authority (CLA): CLA is responsible for issuing the CDSCO manufacturing or wholesale license for IVDs and Medical Devices that fall under class C & D. It is also responsible for the grant of Import licenses for Cosmetics in India.
CDSCO Fee for Product
The Professional Fee For CDSCO Certificate is INR 99,999/- only with Professional Utilities.
CDSCO Registration Document Checklist for Pre Screening of Application
Following is the Key Document Checklist of CDSCO Registration for Pre-Screening of Application
Covering Letter:
It should highlight your purpose behind applying for CDSCO Registration.
Application Form:
- Duly filed, stamped, and signed the original application through the Manufacturer/ importer/ Indian Agent.
- The details of the cosmetic product include product name, product variant, actual manufacturer details, and the categorization of the product.
- Name of your authorized Agent, applying on your behalf.
- Name & Address of the factory premises.
TR6 Challan:
You need to provide this specifying the fees for CDSCO Registration.
Power of Attorney:
- Name & Address of the Indian Agent
- Name & Address of the manufacturer and its manufacturing site according to Form;
- Name of product, variants (if any), and the product’s actual manufacturer to be registered. The categorization of the products should be according to Column 3 of the cosmetics guidelines.
- Duly conjointly signed, stamped, and dated with the name & designation of the signatory by both the Indian Agent & the manufacturer.
- The period for which POA is valid must be mentioned in a power of attorney.
Conclusion
CDSCO Registration is a process of obtaining approval from the regulatory authority to ensure efficiency and quality of Pharmaceuticals, Medical Devices and Cosmetics to be consumed by the masses. CDSCO’s main Job and Objective is to safeguard the Public Health. Make sure to submit necessary documents for the verification process in order to receive a formal revert.
Frequently Asked Questions
What is CDSCO?
CDSCO stands for Central Drugs Standard Control Organisation
Why is CDSCO approval required for Bone Marrow Cell products?
CDSCO approval for Bone Marrow Cell products is required to ensure patient safety, clinical effectiveness, and compliance with Indian regulatory norms governing advanced therapeutic and biological products.
Is a document checklist enough to complete CDSCO registration?
A checklist helps ensure you have all necessary documents ready, but you must follow the full CDSCO Medical Device Registration in India process to get your medical device approved.
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