According to 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. The application is made to the Central Licensing Authority along with some pre-required documents. The license pertaining to the application is granted using form MD-17 by the Central Licensing Authority.
We at CliniExperts help our clients to prepare the dossier for filing a test license application for the intended diagnostic kit. As mentioned earlier, the essential documents should include a cover letter clearly stating the product details like name, class together with the justification of quantity proposed to be imported. Furthermore, Test protocol/Approved clinical investigation plan/ Testing method used for testing the intended diagnostic kit, Quality certificates like QMS, Specimen label and an undertaking stating that the In Vitro Diagnostic kit proposed to be imported shall not be used for 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 and bears a 100% chance of approval within the least possible time.
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