For the import of Class, A, B, C & D In Vitro Diagnostic Kits, the applicant need to submit the documents based on Fourth schedule Part I, Part II and Part III (Appendix I & III, only), in addition to cost as per 2nd timetable of the brand-new clinical tool policies.
An authorized representative holding a permit to manufacture or wholesale license to buy and also distribution released under MDR, 2017, may obtain a grant of import certificate for IVD in Form md 14 to the Authority on behalf of the supplier. After that, the permit would be acquired in Form MD-15.
