CDSCO Registration in India for Medical Devices/ IVD

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    Overview of CDSCO Registration for Medical Device/IVD

    CDSCO registration is a approval from the side of the Central Drugs Standard and Control Organization. The CDSCO is the national regulatory authority responsible for ensuring the safety, efficacy, and quality of medical devices and in vitro diagnostic (IVD) products in India. Under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, medical devices and IVDs are regulated to safeguard public health.

    ELT Corporate makes getting CDSCO registration in India easy and straightforward. We help companies meet all regulatory requirements so they can enter the Indian market smoothly.

    Types of CDSCO Registration We Provides

    Medical Device Registration

    Cosmetics Registration

    What is the Purpose of CDSCO Registration

    Who Can Apply For CDSCO License In India?

    Process Of CDSCO Registration

    Follow the process to apply for the CDSCO Registration In India:

    Our Testimonials

    ELT Corporate’s team secured our CDSCO import licence despite the document challenges required to obtain this licence. Their efficient team guided us throughout the entire process and made it smooth for us.

    Pankaj Gupta

    ELT Corporate helped us get our CDSCO import license even though we had a lot of complicated paperwork to handle. Their team was super efficient and guided us every step of the way, making the whole process easy.

    Ahana

    Getting our CDSCO import license seemed impossible until we found ELT Corporate. Their knowledgeable and professional team handled all the tricky documentation for us. They made the entire process stress-free and quick. 

    Kiran

    Frequently Asked Question

    Do I Need To Register My Medical Device In India?

    Yes, After October 1, 2021 every medical device need to registered. Before importing devices in India medical device import license with the CDSCO is mandatory.

    Who Can Submit A Form For Medical Device License?

    The manufacturer of medical devices, authorized agent or authorized representative, and importers can submit the form for the registration of CDSCO.

    How Much Time Does It Take To Register MD In India?

    To register Medical devices in India every product category have different time duration such as:-

    • Non Notified Class C & D medical devices cab be register currently through the e-portal.
    • All A & B Medical devices will typically takes 6 to 9 months for the device approval.
    • Product with reference country approval takes less time and quicker review response.
    How Are Medical Products Classified In India?

    Medical Devices are classified into 4 categories in India accordance:-
    It is devices according from low risk Class A to high risk Class D.

    • Class A
    • Class B
    • Class C
    • Class D

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