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.

Our Unique Solution

• Our endeavour is to become your reliable regulatory partner
• Be your administrative and commercial point of contact
• Register your products / business
• Keep and host your records and licences
• Import and distribute your medical device products

The many advantages of our solution are :

• You remain independent and autonomous
• You choose all local distributors freely
• You can determine your product selling strategy
• Your regulatory and administrative requirements will be taken care of
• Highly experienced and professional team