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CDSCO Certification

Medical Devices Certification

Medical Devices have always been an object of concern and regulation by the Indian Government. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect. Medical Devices Rules’2017 (MDR) are governed by respective central and state regulatory authorities. Regulatory bodies classify medical devices based upon the associated risk and have defined relatively easy procedures for license applications. Similarly, rules and guidelines have been promulgated by the government for the import of medical devices. Whereby, all one need is to have an Authorized Indian Representative (AIR) to apply for the license. With the reformative intervention and efforts of the government such as the SUGAM portal, obtaining medical device licenses is now an expedite procedure for all the medical devices along with in Vitro medical devices, being imported or manufactured, requires the permission from CDSCO. Here, the approval is given by CDSCO’s State Licensing Authority (SLA) or the Central Licensing Authority (CLA).

Cosmetic Products Certification

Do you know any Cosmetic product, medical device that are being imported in India or manufactured, requires a registration/Licence from the authorities. The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.

As notified by CDSCO, any product which is being rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

Import of cosmetics into India is regulated through a system of registration by the CDSCO under the provisions of the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020.

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