CDSCO Medical Device Registration for X-Ray Machine
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CDSCO Medical Device Registration for X-Ray Machine - Procedure, Documents, Benefits
CDSCO, or the Central Drugs Standard and Control Organisation, is India’s National Regulatory Authority for cosmetics, pharmaceuticals, and medical devices. It is a highly influential organization in the country.
Within the CDSCO, the Drug Controller General of India (DCGI) oversees pharmaceuticals and medical devices. The CDSCO operates under the Ministry of Health and Family Welfare and is responsible for regulating these products under the Drugs and Cosmetics Act of 1940 and Rules of 1945.
What is an X-Ray Machine as a Medical Device?
An X-ray machine utilizes X-rays, a form of electromagnetic radiation, to create images of the inside of an object. It typically consists of an X-ray generator and an X-ray detector. X-ray machines are used for painlessly diagnosing, monitoring, and treating many medical conditions. They provide visualization of internal structures of the body and support medical and surgical treatment planning.
Documents For CDSCO Registration for X-Ray Machine
ollowing are the documents required in the CDSCO Registration for X-Ray Machine:
- Application Form (Form 40)
- ISO 13485 Certificate
- TR6 Challan
- Undertaking that only authentic details are provided
- Power of Attorney
- Full quality assurance certificate
- CE Design certificate
- Declaration of conformity
- Device master file
- FSC (Free Sale Certificate)
- Plant master report
CDSCO Fee for Product
The taxvilla fee for the CDSCO certificate is INR 99,999/- only with taxvilla
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