For development of Therapeutics, Devices & Diagnostics


Faster Approvals Leading to Enhanced Access to Markets !

In order to legally import and market diagnostic and In-Vitro Diagnostic device/s in India, a manufacturer needs to be compliant to Indian regulations and legislation. At present, certain “notified” diagnostics and In-Vitro Diagnostic (IVD) Devices are regulated under the provisions of the Drugs and Cosmetics Acts & Rules.

In brief, there is a set procedure of application submission, product testing, registration dossier submission, review and approvals from various stakeholders that are required to facilitate Product Approval / Market Authorisation. The approvals are usually in the form of No Objection Certificates/Letters, Approval Letters, Licences etc.,

Vyomus Consulting provides end-to-end Diagnostic / IVD Product Registration / Market Authorisation Services as well as Authorised Agent Services to all importers and manufactures of diagnostic products. This end-to-end service offering will help you import, manufacture, test, conduct clinical trials and distribute your diagnostic products in India (Market Authorisation), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.

This service offering includes Product Testing Vendor Identification & Management, various stakeholder regulatory submissions, approvals management, independent audit, regulatory reporting, regulatory dossier review and submission to the regulator.

Our services include the following :

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