Medical Devices that are CE marked and/or 510(k) - Registration in India?

Morning chaps and chapesses! I'm afraid I have another question for you all. I have had a quick search of the forum for an answer but have been unable to find one. Apologies if I have simply missed it.

Is there currently any requirement for the registration of medical devices in India that are CE marked and/or 510(k)'d? If so, what is the process please?

Cheers

BM

Re: Medical Device Registration India?

Please explore www.cdsco.nic.in Click on Medical Devices at bottom left of the page.
You will get to see the guidelines for import and manufacture of medical devices and its latest updates.
Hope the time you spend in exploring gets you your required information.

Re: Medical Device Registration India?

Burgmeister said:

Morning chaps and chapesses! I'm afraid I have another question for you all. I have had a quick search of the forum for an answer but have been unable to find one. Apologies if I have simply missed it.

Is there currently any requirement for the registration of medical devices in India that are CE marked and/or 510(k)'d? If so, what is the process please?

Cheers

BM

Click to expand...

Refer CDSCO Guidelines for Import and manufacture of Medical Devices

Re: Medical Device Registration India?

bio_subbu said:

Refer CDSCO Guidelines for Import and manufacture of Medical Devices

Click to expand...

OK I have read that. Am I correct in saying that you should provide the full dossier A-G even though all of this information has been assessed for CE/510(k)? Also does the fee of $US 1000 for each device cover a 'system'?

Thanks

Re: Medical Device Registration India?

Yes. CDSCO would need the file which answers the A - G of the registration of Medical device irrespective of CE or the 510K assessment.
By your word "system" it should mean a group of medical devices which are having variation in sizes or shape without any change in the material or method of use. This is clearly stated in the guidelines document.

Re: Medical Device Registration India?

somashekar said:

By your word "system" it should mean a group of medical devices which are having variation in sizes or shape without any change in the material or method of use. This is clearly stated in the guidelines document.

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The device in question is sold as a system and includes a generator, handset, associated cabling and probes all of which are useless without the other parts. So if it was registered as a system would $1000 cover it or would it need one registration for the generator, one for the handset, one for the cable etc etc. That was the point I was clumsily trying to make.

Re: Medical Device Registration India?

As I do not know what your medical device is, all I can say is that if your device is not classified under any of the following then this regulation does not apply to you ...
1. Cardiac Stents.
2. Drug Eluting Stents.
3. Catheters.
4. Intra Ocular Lenses.
5. I.V. Cannulae.
6. Bone Cements.
7. Heart Valves.
8. Scalp Vein Set.
9. Orthopedic Implants.
10. Internal Prosthetic replacements.
11. Spinal Needles
12. Insulin Syringes
13. Three Way Stop Cock as an accessory of I.V.Cannula/Catheter/Perfusion Set
14. Endotracheal tubes
15. Introducer Sheath
16. Annuloplasty Ring
17. Cardiac Patch
18. Cochlear Implant
19. Extension Tube
20. Close Wound Drainage Set
21. Trachestomy Tube with / without Cuff
22. AV Fistula Needle
23. Extension Line as a accessory of Infusion Set
24. ANGO kit/PTCA/Cath Lab Kit
25. Heart Lung Pack
26. Measure Volume Set
27. Flow Regulator as a accessory of Infusion Set
28. Hemodialysis Tubing Set / Blood Tubing Set/Arterial Venous Tubing Set
29. Dialysis Catheter

Re: Medical Device Registration India?

somashekar, I thank you for your continued help in this, I really appreciate you taking the time & trouble to contribute. I can confirm that the device in question is not on your list. So, if this regulation does not apply does that mean that there would be no requirement to register or that I should follow a different guideline/regulation? I apologise if I sometimes (often??) appear to be slow on the uptake.

Once again I thank you and all the contributors on this excellent forum for making my job so much easier!!

Re: Medical Device Registration India?

Burgmeister said:

The device in question is sold as a system and includes a generator, handset, associated cabling and probes all of which are useless without the other parts. So if it was registered as a system would $1000 cover it or would it need one registration for the generator, one for the handset, one for the cable etc etc. That was the point I was clumsily trying to make.

Click to expand...

Hi

There are so many formalities/procedures to get register to import your product in India. Imports of medical devices are controlled by central Government and applications for import are entertained directly by the CDSCO. The procedure includes registration of the manufacturing firm and grant of form10 license.

Application in form 40 includes fees, information on schedule DI (plant details) and DII (product details) and power of attorney.

Issue of form 10- It is required for an importer to import medical devices from a registered manufacturer.

Application in form 8, undertaking in form 9 with required fee, wholesale/manufacturing License of the importer.

Test License (form11) -This is required for importing small quantity of Medical devices for test/ Analysis including clinical trail study.

I suggest you to contact them directly for your specified product and registration fee details. The CDSCO contact details can be accessed from here.

Regards
S. Subramaniam

Re: Medical Device Registration India?

Perhaps the other customs regulation applies per your classification of product. Do check with your importer here in India.