Catchment of the Test License for the Regulation of Medical Devices in India

Abstract

The medical device industry in India is gaining momentum and is expected to grow rapidly. Given the significant impact of medical devices (MD) on patient health, a robust regulatory framework that combines policies, laws, regulations, and approvals is necessary to ensure adherence to standards before market entry. To initiate regulatory approval, test license is the preliminary step. It is required to manufacture or import materials in small quantities for specified purposes; for example, testing, training, examination, evaluation, demonstration, and clinical investigation under India’s Medical Devices Rules (MDR) 2017. In general, as the associated risk of the device increases, the testing or evaluation parameters required to establish its safety and efficacy also increases. In this regard, test license is introduced so that manufacturers or importers must navigate to ensure compliance for the generation of data, particularly in the context of quality aspects of a MD or in vitro diagnostics (IVD), such as its design verification and validation, material of construction, testing, functionality, durability, sterility, biocompatibility, electrical safety, usability, and many more. Therefore, the present paper deals with the basic requirement and the details of the requisite documents for the grant of test license for the aforementioned purposes. It also aims to address the challenges so as to reduce the time-lapsed, effort, and financial burden to the applicant.