Medical Device Registration Process for An X-Ray Machine Manufacturer in India.

Medical Device Registration Process for An X-Ray Machine Manufacturer in India.

What is an x-ray machine?
An x-ray machine sends individual x-ray waves through the body. The images are recorded on a computer or film. Structures that are dense (such as bone) will block most of the x-ray waves and will appear white. Metal and contrast media (special dye used to highlight areas of the body) will also appear white.
Documents Required For Medical Device 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
Schedule D(I)
Declaration of conformity
Device master file
Free sale certificate
Plant master report
Free sale certificate/ certificate from the foreign government