In order to legally register, import and market, sell your medical products in India you need to be compliant to Indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licences in India, a legal India authorized Representative / Agent with the above needs is to be formally appointed. This authorized Representative will also be held responsible for pre certification and post market surveillance inquiries.
Lexium will represent the client’s organization as the official Indian authorized representative /Agent in accordance with India applicable regulatory legislation. The drugs and cosmetics Act and Rules.
Only one Indian authorized representative office is needed for the whole country. Lexium will represent the client legally in India without any commercial conflict of interest activities like product distribution, product marketing, product sales etc.
We will pursue the application assessment and notify when the registration is accepted.
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