India Local Networking Group

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  • 1.  Power of Attorney (Indian AR)

    Posted 24 days ago

    Dear all

    I am a manufacturer of medical devices in EU and I have a question regarding the Power of Attorney. 

    One of our distributors (who sells our products with their own labels and name) want to export our MDs to India and needs to sign an exclusive Power of Attorney with their Indian Authorized Representative to enter the market.

    Now, my question is, as they are our distributors and sell our product with a different name/commercial code, could we then as manufacturer of the same devices (although with different product name and different commercial code, and under our own name on the labels) sign another Power of Attorney with a different Indian Authorized Representative once we also enter the Indian market? 

    Would the exclusive PoA signed by our distributor prevent us from signign another PoA with a different Indian Local Agent (for the same device with a different name and commercial code, but covered by the same EU certificate and referring to the same Technical Documentation)?

    Thank you very much for any insight you could give me.

    Best regards



    ------------------------------
    Federica
    Thema s.r.l. - ENTERPRISE
    Imola
    Italy
    ------------------------------


  • 2.  RE: Power of Attorney (Indian AR)

    Posted 24 days ago

    Dear Federica

    Thank you for sharing your inquiry regarding Power of Attorney (PoA) requirements for entering the Indian market with your medical devices. I appreciate the opportunity to provide guidance on this matter.

    Regarding the exclusive PoA signed by your distributor for exporting your devices to India, it's important to assess the terms of the agreement to ensure clarity on the scope and limitations imposed. While your distributor may have secured exclusive rights for specific territories or markets, such agreements typically pertain to the particular brand or product line they represent.

    As the manufacturer, you retain the prerogative to appoint additional agents or representatives for your products, even if they are marketed under different names or commercial codes. The critical consideration lies in whether the exclusive PoA obtained by your distributor contains provisions that prohibit you from appointing other agents within the same territory.

    Prior to taking any action, I recommend conducting a thorough review of the existing PoA and consulting legal expertise if needed to ascertain compliance and mitigate potential conflicts. If the exclusive agreement does not explicitly restrict you from appointing another Indian Authorized Representative for your devices, you should be able to proceed with appointing a different agent for your independent market entry.

    Furthermore, since your devices maintain the same EU certificate and technical documentation, there should be no regulatory obstacles to appointing a separate Indian Authorized Representative for your products.

    To summarize, while the exclusive PoA signed by your distributor may impose certain limitations, it should not hinder you from appointing another representative for the Indian market, especially considering the distinct branding and commercial codes associated with your products.

    Please feel free to reach out if you require further assistance or clarification on this matter. We are committed to supporting you in navigating the regulatory landscape and facilitating a seamless entry into the Indian market.


    Best regards,
    Harsh Jadav 
    +91-8200420074
    Regulatory Affairs 



    Original Message


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