In case of new In vitro Diagnostic Kit, the applicant shall obtain prior permission in Form MD-29 from the Central Licensing Authority and no licence to import any class of such IVD shall be granted without such permission.
An applicant filing an application for import or manufacture of the intended IVD which does not have a predicate IVD , after completion of its Clinical Performance Evaluation shall be made to the Central Licensing Authority in Form MD-29 either by an authorised agent in case of import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule.
According to the new Medical Device Rules, 2017 a “predicate device” is defined as a device, first time and first of its kind, which is approved for manufacture for sale or for import by the Central Licensing Authority and has the similar intended use, material of construction, and design characteristics as the device which is proposed for licence in India. An applicant filing for the import/manufacture of New In-Vitro Diagnostic kit which does not have a predicate IVD kit is required to submit substantial equivalence with the predicate device as a prerequisite for the submission of the application. A claim of substantial equivalence does not mean that the proposed medical device and predicate device are identical. Substantial equivalence shall be established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.