The recent notification from the Ministry of Health, GoI (MoHFW), stating that any medical device, including software, will be regulated as a 'drug' under the Drugs and Cosmetics Act (if they are used for specific categories), triggered the need to delve deeper into the topic as there are a number of questions that need clarification e.g What are the specific regulatory changes? How does this impact the privacy and prevailing data laws in the country?

The APACMed Webinar on the theme - Software as a Medical Device (SaMD): Demystifying Connected Health Regulations, will provide answers to these questions and more, along with sharing of global best practices on SaMD.