CDSCO Drugs Import License
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CDSCO Test License for Medical Device- Process, Documents, Benefits
CDSCO is India’s National Regulatory Body for Cosmetics, Pharmaceuticals, and Medical Devices. The CDSCO Test License is issued by the DCGI under the Central Drugs Standard Control Organisation.
The CDSCO Test License for Medical Devices is a process to obtain approval from the regulatory authority, ensuring the efficiency and quality of drugs, medical devices, pharmaceuticals, and cosmetics.
What is a CDSCO Test License for Medical Devices?
Under the Drugs and Cosmetics Act, CDSCO is responsible for approving new drugs, conducting clinical trials, establishing standards for drugs in the country, and coordinating activities of state drug control organizations to ensure uniform enforcement of the Drugs and Cosmetics Act.
The CDSCO grants licenses for testing, importing, or manufacturing medical devices after carefully evaluating each application. These licenses are granted for the purpose of importing, selling, and distributing medical devices, with government regulations to be followed to remove any hindrances.
Documents for CDSCO Test License for Medical Devices
Documents required in CDSCO Test License for Medical Devices are as follows:
- Identity proof of the applicant
- Address proof of the applicant
- Undertaking allotted by a Government Authority
- Copy of BE or BA Site Registrations as issued by CDSCO in case of BE or BA approved sites Registration
- Manufacturing License or Wholesale Licenses in case of Import or Manufacture of Drugs/Blood Product Registration/Test license Registration
- Form-12
- TR-6 Challan utilization or justification
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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