Importing Diagnostic kit from US, UK

N

nike.shah

#1
Hi,

We are looking to import diagnostic kits from the UK and US into India? We have a general IEC (Import Export Certificate) code. Do we need anything else to import the same?

In the near future, we are also expecting blood samples for conducting diagnostic tests from neighbouring countries. What approvals, if any, do we need for that? Any help will be appreciated.

Regards,
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Another quick "Bump". My Thanks in advance to anyone who can help with this one.
 

somashekar

Staff member
Super Moderator
#4
Hi,

We are looking to import diagnostic kits from the UK and US into India? We have a general IEC (Import Export Certificate) code. Do we need anything else to import the same?

In the near future, we are also expecting blood samples for conducting diagnostic tests from neighbouring countries. What approvals, if any, do we need for that? Any help will be appreciated.

Regards,
For all your answers visit CDSCO and contact them directly for further clarifications...
 
N

nike.shah

#5
Thanks Somashekar... will do that... have been browsing their site for the last couple of days now.
 
S

SQ2012

#6
You will have to get the import license from the DCGI. Diagnostic kits for HIV & Hepatitis are notified by DCGI thus requiring their registration. The non-notified kits do not require product registration.
Moreover kits for some diseases like Malaria, Dengue, Chikungunya, Syphilis, Typhoid, Tuberculosis, and Cancer markers require validation by NABL labs.
The import guidelines and checklist are available on CDSCO website.
 
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