IVDzone Consulting is a regulatory and development partner helping Medical Devices and In Vitro Diagnostics (IVD) companies commercialize their products in India. From ideation to commercialization, we design and implement efficient and effective regulatory and product development solutions which integrate science, regulations and business objectives, to overcome product commercialisation challenges.

In order to legally import and market or manufacture medical device/s and or IVD’s in India, a manufacturer needs to be compliant to Indian regulations and legislation. In summary, medical device & in vitro diagnostic medical devices manufacturers who wish to import and market their products in India, have to register their manufacturing site/s and product/s through their registered office in India, or their Subsidiary or through an Importer or an India based Authorised Agent.An organisation which proposes to manufacture a medical device or IVD product in India will have to register itself through CDSCO.