CDSCO - Authorized Agent Support - Medical Device

CDSCO Authorized Agent Support

Medical Device

For Authorized Agent Support, Please fill the below form


    CliniExperts can act as your authorized agent and provide end-to-end solutions to carry out the import of medical devices in India. The team of experts at CliniExperts facilitates the hassle-free one-time registration process and thus launch of medical devices in India in compliance with Indian regulatory requirements.

    Authorized Agent For
    Medical Device – Overview


    A foreign company who doesn’t have its establishment in India, wants to enter India market, then they can appoint an authorized agent to register and market their products in India. An “Authorized Agent” means a person or entity in India authorized by the foreign company. The authorized agent will be responsible for the import and business activities of the foreign company in India including compliance to the provisions of the Drugs and Cosmetics Acts in all respects. Authorized Agent must possess a valid wholesale license meant for the sale and distribution of products or services in India and should be able to file an application to Central Licensing Authority for Medical Device registration in India.

    Who Would Need
    An Authorized Agent Service?


    Any foreign company who want to capture the Indian market but does not have its business operations or partner in India.

    India Regulatory Expert Series

     

    Services CliniExperts Provides As An Authorized Agent

     

    It is difficult for a foreign manufacturer to manage its operations in India due to involvement of heavy cost, yearly compliance, accounting requirements, and taxation policy and closure clauses. CliniExperts is a leading regulatory and business consultancy that provides you with the continuous support to market your products (medical devices) in India. The team of experts at CliniExperts offers:

    Support for import assistance and custom clearance

    Warehouse and CFA support for product distribution

    Support in recognizing potential distributors for launching products in India

    Support related to legal certifications and post-marketing surveillance queries

    Responsibilities of
    Authorized Agent

    Must possess a valid wholesale license meant for the sale and distribution of products or services in India

    Should file an application in Form MD-14 to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare for the grant of import license for medical devices in India

    Needs to make an application to the central licensing authority for the renewal of the license along with the prescribed fee post completion of five years from the grant of license

    Is fully responsible for all legal certifications and queries related to post-market surveillance

    Can recall medical devices at any stage if needed

    Essential Tips

     

    Two main requisites while preparing for the process of license application are:

    Possession of wholesale license for sale and distribution of medical devices in India


    Appointment as an authorized agent

    Expert Advise

    With respect to import of medical devices, the foreign manufacture has to submit

    Power of attorney, allowing authorized agent to market their products in India on their behalf

    Free Sale Certificate of their finished product in the GHTF countries

    The documentary evidence need to be submitted to the central licensing authority at the time of grant of license and subsequently as and when needed.

    Primary Service

    Import license for predicate Medical Device (Form MD 14, 15)

    Regulatory Body: CDSCO   Application Forms: Form MD 14, 15

    Meet all your Regulatory Compliance needs. CliniExperts' professionals help you plan and streamline regulatory approval processes.


    Who Can Apply

    An authorized Indian agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or wholesale License FORM 20B & FORM 21 B (sale or distribution) as per the CDSCO guidelines. The agent will make an application to get the grant of medical devices import license by applying through the Sugam online portal.

    Other Related Services

    Wholesale License (Form 20B, 21B)


    Importer | Regulatory Body: SLA

    CliniExperts offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.

    New Medical Device permission (Form MD 26, 27)


    Importer | Regulatory Body:CDSCO

    Get experts assistance to avail Permission to import or manufacture medical device which does not have its predicate device in India as per MDR 2017

    Test License to import Medical Device (Form MD 16, 17)


    Importer | Regulatory Body:CDSCO

    Need a permission to import medical device in India to demonstrate its performance? CliniExperts’ professionals have expertise and assist you in securing a medical devices test license for importers in Form MD 17 by CDSCO.

    Frequently Asked Questions

    Why would I require authorized agent support?

    For a foreign company to market its product in India, the prime requisite is registration of products by an Indian establishment. Foreign companies without Indian establishment or partners need to have an authorize agent to undertake import of products in India on their behalf.

    How I will be benefitted to appoint you as my authorized agent instead of my existing distributor in India?

    In order to initiate operations in India, only one Indian establishment is needed, In case you have your distributor and you would like to change your distributor afterwards, registration process needs to be carried out again. With CliniExperts, registration needs to be done only one time. You may add or change as many distributors as needed.

    Apart from being an authorized agent, what additional services will be offered by CliniExperts?

    Additional services offered by CliniExperts include:

    • Import assistance and customs clearance support
    • Warehouse and CFA support to distribute your products
    • Distributor’s identification to identify and map potential distributors to launch your products in India
    • Post-market surveillance and Pre-certification support

    Which sales model is being offered by CliniExperts?

    CliniExperts is an emerging business consultancy that focuses on all your business needs right from initiating registration of license, assistance in import of products to seamless logistics support throughout the process.

    What are the legal compliances needed to opt these services?

    All the legal compliances including pre-certifications, post-marketing surveillance queries, product recall request or any other request to be placed are taken care by the appointed authorized agent.

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