Course abstract

Medical devices and IVDs are an upcoming area and there are lots of new developments. It is important to know the right information as regulations can be misinterpreted. This knowledge when disseminated by the regulators themselves along with subject experts and experienced trainers, will have a profound impact. Being an online course will address a larger section of the public. Making it a ‘free course’ will allow many to acquire knowledge in the comfort of their home without paying any money. Demonstration of safety, efficacy, and performance of the medical device and in vitro diagnostic (IVD) kit for use in humans is essential before the product can be approved for import or manufacture and marketing in the country. Medical devices are currently regulated under the definition of ‘drug’. Recent amendments made in the Rule by incorporating specific rules i.e. “Medical Devices Rules 2017’’ [G.S.R. 78 (E) dated the 31st January 2017] are published and are mandatory with effect from 1st January 2018. These Rules provided requirements for import, manufacture, clinical investigation, medical device and in vitro diagnostics. All these had been effectively addressed in this course launched in early 2019 with 10 lectures as a four-week course. This online course (version 1.0) was attended by 657 participants (Jan - Mar 2019). A brainstorming series of discussions were steered by CDSA with CDSCO for incorporating the new updates. The feedback received from version 1.0 participants were sought. Also, the deliberations from various face-to-face programs on medical devices and IVDs that were conducted by CDSA and CDSCO were incorporated to decide the content for version 2.0. This now had 12 lectures spread over 4 weeks (online course). This will involve 4 weekly assignments and a final exit assessment. 4 new lectures have been added in version 2.0