Hi

Our Co. is based at India, manufacturing IVDs i.e Malaria test kits, Dengue Test kits, Pregnancy test kits. We have obtained the local licence to manufacture the IVDs. We manufacture and supply these kits only in indian market and dont have any plan to supply outside india in near future.

Since in one of the tender there was a requirement for ISO 13485 certified vendor, We are now currently pursuing the ISO 13485 Certification. Since in India there are no regulatory requirements on IVDs, Do i still need to comply to all the harmonized standards published by EU??

Also do i need to demonstrate compliance to the GHTF guidance docs..

Can you guys help us out..

For ISO13485 you don't necessarily need to meet any other standards, although ISO14971 is typically considered linked to ISO13485.

You will need to comply with the new Indian medical devices regulations (I believe they come into force very soon), and possibly the Indian Pharmacopoeia.

What I would say is that finding out what international standards already exist for your products, and doing a gap analysis. So for future development, you can gradually bring your products into line.

Meeting GHTF guidelines will only be necessary if the Indian government requires it. However ISO13485 requires that you maintain a technical file, so why not prepare a technical file that meets the GHTF STED guidelines anyway?

The bottom line is that finding out what the global requirements are ahead of time, and working to fulfill them over time, can save a lot of painful effort later (when the Marketing Department announce they have just won an order in the US or Europe etc).

Finally I would strongly recommend finding a competent registrar for ISO1348, there is little point of spending significant money on something that doesn't hold up.

Hi Naveen,

Welcome to the Cove :bigwave:

Roland has given good answers.

Hi Naveen

Indian regulations cover IVDs as well, but to certain specified critical products. It will be self-explanatory, if you go through Drugs & Cosmetics Act, 1949 Schedule C (1) Sub-section 10 & 11 that incorporates the requirement of regulation of IVDs.

Hi Naveen

Indian regulations cover IVDs as well, but to certain specified critical products. It will be self-explanatory, if you go through Drugs & Cosmetics Act, 1949 Schedule C (1) Sub-section 10 & 11 that incorporates the requirement of regulation of IVDs.

Hi ganeshkumara,

Thanks and Welcome to the Cove :bigwave:

Hi

Thanks for all of you for clarifications.

We have now identified the list of standards (from harmonised standards) applicable to IVDs and started working towards compliance.

Thanks once again
Naveen :):thanx:

Hi

Thanks for all of you for clarifications.

We have now identified the list of standards (from harmonised standards) applicable to IVDs and started working towards compliance.

Thanks once again
Naveen :):thanx:

Naveen, would you like to share with the cove members ?