As per current regulations for In Vitro Diagnostic Kits in India, any person who intends to sell their In Vitro Diagnostic Kits in India would require import registration under Indian laws.
Indian law does not allow the foreign manufacturers to file an application directly to CDSCO. It requires a foreign manufacturer or any company which does not have a local presence or a registered office in India to appoint an authorized agent/registration holder having a valid Wholesale License to perform the registration process on their behalf. All the applications for import of In Vitro Diagnostic Kits will be filed by Authorized agent only.
An authorized agent means a person including any firm or organization who has been appointed by an overseas manufacturer through a power of attorney to undertake import of In Vitro Diagnostic Kits in India.
We at CliniExperts hold a valid Wholesale License (Form 20B and 21B) enabling us to act as Authorized agent for our clients which shortens the time of foreign manufacturer to set up their office in India and facilitating the hassle-free launching of the product in India.
For more information and detailed assistance, or to appoint us as your Authorized agent, please feel free to contact us at email@example.com or +91-76720-05050