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I would like to know what are the regulations for importing a IVD diagnostic kit in India.
The IVD kit contains - Syringe for blood draw, PAX gene blood RNA tube (contains a specific reagent) and a cooling system.
The procedure will be that, this kit will be shipped from U.S to the physician in India and he will draw ~10ml blood from the patient using the equipment in the kit and ship it back to a lab in U.S where diagnosis will be conducted. Based on this description I would like to know :
a) What will this kit be classified under? (A,B,C,D?)
- This is really not a diagnostic kit as diagnosis will be conducted in a separate lab in U.S. The kit just contains equipment for a blood draw procedure.
b) What are some of the import regulations for this kit?
c) Will this blood sample be allowed to be exported out of India.
Note: This will be a case by case process. if a physician wants to conduct this test on a patient, he will order it and ship the blood sample back to U.S
d) Since this test in not registered in India. Does it require any clinical trials?
- Where can I find information on the process for clinical trials for such a
test ?
Any help to answer these questions is greatly appreciated!
Thanks

The IVD kit contains - Syringe for blood draw, PAX gene blood RNA tube (contains a specific reagent) and a cooling system.
The procedure will be that, this kit will be shipped from U.S to the physician in India and he will draw ~10ml blood from the patient using the equipment in the kit and ship it back to a lab in U.S where diagnosis will be conducted. Based on this description I would like to know :
a) What will this kit be classified under? (A,B,C,D?)
- This is really not a diagnostic kit as diagnosis will be conducted in a separate lab in U.S. The kit just contains equipment for a blood draw procedure.
b) What are some of the import regulations for this kit?
c) Will this blood sample be allowed to be exported out of India.
Note: This will be a case by case process. if a physician wants to conduct this test on a patient, he will order it and ship the blood sample back to U.S
d) Since this test in not registered in India. Does it require any clinical trials?
- Where can I find information on the process for clinical trials for such a
test ?
Any help to answer these questions is greatly appreciated!
Thanks