Regulatory requirements for medical devices including in vitro diagnostics in India (Version 2.0)

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

INTENDED AUDIENCE : • Medical device industry• in vitro diagnostics (IVD) manufacturers• Innovators or start-ups involved in either medical device or IVDs• Regulatory affairs personnel• Human ethics committee members• Clinical trial/research team members• Any person interested to acquire knowledge in this areaPRE-REQUISITES : There is no pre-requisite to undertake this course.INDUSTRY SUPPORT : Medical devices, IVD companies,Research/Academic Institutions, Biomedicalresearch organizations, Regulatory authorities, Medical colleges, Contract research organizations

COURSE LAYOUTWeek 1 : Lecture 1: Introduction: Medical device and in vitro diagnostics Types of devices including combination devices and Drug Vs device Vs IVDLecture 2: Medical Device Rules, 2017: Implications on medical devicesLecture 3: Classification. Labeling of medical devices Week 2 : Lecture 4:Standards of medical device, quality assurance, and testingLecture 5: Biocompatibility studies on medical devicesLecture 6A: Clinical investigation of medical devices Week 3 : Lecture 7: Quality assurance and quality management systemLecture 8: Manufacture of medical devices and IVDs.How to obtain a license to manufacture a medical device?Lecture 9: Risk management system for medical devices (ISO 14971) Week 4 :Lecture 10: Inspection of medical device and IVD establishmentsLecture 11: Import and export of medical devices and IVDsLecture 12: Medical device regulation: International practices