CDSCO Medical Device Registration for Organ Preservation Solution
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CDSCO Medical Device Registration for Organ Preservation Solution - Process, Importance, Documents required
CDSCO is the Central Drugs Standard Control Organisation which is the National Regulatory Body for Cosmetics, Pharmaceuticals and Medical Devices.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates Pharmaceutical and Medical Devices and its positioning with the Ministry of Health and Family Welfare.
What is an Organ Preservation Solution?
Organ Preservation is a process of keeping organs viable for transplantation after they are removed from the donor body to transplant them into the receiver’s body.
The main methods of Organ Preservation are Static Cold Storage and Machine Perfusion. The process includes removing, storing and transporting. The goal of Organ Preservation Solution is to maintain the organ’s function and viability, allowing for successful transplantation.
Documents required in the CDSCO Registration for Organ Preservation Solution
Important documents required in the process are as follows:
- Form under the Drugs and Cosmetic Rules
- ISO 13485 Certificate
- Details of the Manufacturer
- Full Quality Assurance Certificate
- Nature of activity (import/export)
- Undertaking that all the information provided is authentic
- Brand Name (if registered under the Trade Marks Act, 1999)
- FSC / Certificate by the Foreign Government
- Device Master File
- Plant Master File
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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