Laboratory Automation Classification in India

L

Lu288

#1
Hi all,
I am from Italy and I am trying to classify a device that must be sold in INDIA.
We produce a laboratory automation which in EU is classified as an IVD; the device simply transports blood samples contained in tubes, does not use reagents.

A consultant told me that my device must be registered to Indian Health Ministry and that tests in Indian laboratory are required.

I am not really convinced expecially because other experienced professionals told me that laboratory automation are not regulated at all.

Does someone have any idea/experience?

Thanks all!:thanx:
 
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G

GPjeri

#2
I'd need to know more about how it transports blood; is it just a sample prep instrument and therefore general instrumentation per the IVDD? I will tell you that for India, I recently had to send our Declaration of Conformity for our tech file, and an apostilled CFS for an IVD platform, but this is for a reagent processing instrument. With the new regs in India there seems to be confusion among distributors there as to what is truly required, and my attempts for clarification from the MOH have gone unaswered. If you have a distributor I would go to them, if you have an in country rep, go to them. Good luck.
 

sreenu927

Quite Involved in Discussions
#3
Only high risk IVDs such as HIV, HCV kits or devices need registration in India.
I totally didn't understand the intended use of your device... as per Indian regulations, non-critical IVDs don't require registration.

See below list for what needs to be registered:
CLARIFICATION WITH REGARD TO CONTROL OF VARIOUS MEDICAL DEVICES (DATED : 20.03.2009)

It is clarified that following sterile Medical Devices are also covered under the provision of Drugs & Cosmetics Act and Rules :

1. Spinal Needles
2. Insulin Syringes
3. Three Way Stop Cock as an accessory of I.V.Cannula/Catheter/Perfusion Set
4. Endotracheal tubes
5. Introducer Sheath
6. Annuloplasty Ring
7. Cardiac Patch
8. Cochlear Implant
9. Extension Tube
10. Close Wound Drainage Set
11. Trachestomy Tube with / without Cuff
12. AV Fistula Needle
13. Extension Line as a accessory of Infusion Set
14. ANGO kit/PTCA/Cath Lab Kit
15. Heart Lung Pack
16. Measure Volume Set
17. Flow Regulator as a accessory of Infusion Set
18. Hemodialysis Tubing Set / Blood Tubing Set/Arterial Venous Tubing Set
19. Dialysis Catheter


Also, you can visit the website
http://cdsco.nic.in/index.html

Regards,
Sreenu
 
L

Lu288

#4
Most of all, thank you for your reprlies, very helpful.

Our device is an automation system, a track on which tubes containing blood are transported in order to be sent to analyzers (not our product).
After being analyzed the tubes are released on the transport system again and stored in a large fridge.

Hope this description was more precise.
Anyhow I really do not think it is a high risk product, I woold say it is general instrumentation.

Thanks again!:)
 
D

dssInd

#5
Hello,
We want to import a prep kit to India. Its basically an IVD which currently do not require to be registred in India other than Critical IVDs. This kit also contains syringes and needles for blood collection. In this case, would this require to be registered?
 
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