CDSCO Medical Device Registration for Dialysis Machine
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CDSCO Medical Device Registration for Dialysis Machine - Process, Documents required, Fee
CDSCO, or the Central Drugs Standard Control Organisation, is India’s National Regulatory Body for cosmetics, pharmaceuticals, and medical devices.
The Indian Government has announced its intention to subject all medical devices, including implants and contraceptives, to review by the Central Drugs Standard Control Organisation.
What is a Dialysis Machine as a Medical Device under CDSCO?
The Dialysis Machine mixes and monitors the Dialysate. Dialysate refers to the fluid which helps to remove unwanted products from the blood. It also helps electrolytes and minerals to reach their proper levels in the body.
A Dialysis Machine is a Medical Device that filters out extra waste and fluid from the body. It also regulates the blood pressure and the blood flow in the body.
Documents required in the CDSCO Medical Device registration for Dialysis Machine
Following are the important documents required in the CDSCO Medical Device Registration;
- Form 40
- ISO 13485 Certificate
- Full Quality Assurance Certificate
- CE Design Certificate
- Undertaking that all details provided are authentic
- Free Sale Certificate or Certificate from the Foreign Government
- Plant Master Report
- Device Master File
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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