Diagnostic Kit – For Importers

Diagnostic Kit – For Importers

Earlier, there were no medical device regulations existed in India. However, today there are registration procedures for certain types and classes of In Vitro Diagnostic Kits regulated under the provisions of Drugs and Cosmetic Act & Rules.

 

Any authorised agent holding valid license to manufacture or wholesale license issued under MDR, 2017, can apply for grant of import licence for IVD to the Central Licensing Authority.

 

For importing any IVD, only a single step process is required. The process for granting the permission to import the IVD is simplified and certain. New Rules allows multiple importer of a same product. Each importer needs to obtain separate Import License.

Authorized Agent / Registration Holder Support

An authorized agent means a person including any firm or organization who has been appointed by an overseas manufacturer 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 facilitating the hassle-free launching of the product in India.
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Permission for Import License (Form MD-14, Form MD-15)

An authorised agent holding license to manufacture or wholesale licence for sale and distribution issued under MDR, 2017, may apply for grant of import license for IVD in Form MD- 14 to the Authority on behalf of the manufacturer. Thereafter, the license would be obtained in Form MD-15. Our technical team at CliniExperts help our clients to obtain Import License.
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Permission for Test License to Import In-vitro Diagnostic kit (Form MD-16, Form MD-17)

As per the new medical device rules, 2017 an applicant who intends to import small quantities of In Vitro Diagnostic Kits, for the purpose of examination, test or analysis can apply in form MD-16 provided that the imported In Vitro Diagnostic Kits under Form 17 should not be used for any commercial purpose.

 

We at CliniExperts help you in hassle free preparation and submission of these documents and undergoing the rigorous application procedure. Our team of experts will ensure that your application is flawless, enabling the fast pace grant of license.
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We at CliniExperts are well versed with the latest rules and guidelines related to In Vitro Diagnostic Kits issued by the CDSCO. Our in-depth knowledge of the rules allows us to ease the process of compilation of documents required for the import license approval for In Vitro Diagnostic Kits manufactured by foreign manufacturers and expedite the process on behalf of the manufacturer.

 

 

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