MDRTA – The Future of Medical Device Community

MDRTA (Medical Device Rules Tech Assistant) is a product of Yugasa Group of Companies. Yugasa Software Labs is a software development company which works on niche technologies and is pioneering AI solutions in the health sector. Yugasa has filed various patents in the technology domain and has worked in more than 26 countries. Yugasa believes in democratising tech solutions for the world and keeps ease of use paramount. Yugasa’s innovative solutions are being used at scale by millions of users across the globe. The team has a sharp focus on the health care industry of India and it is working closely with various hospitals across the country.

Medical Device Industry of India

According to a report by the India Brand Equity Foundation (IBEF), the Indian medical device industry is expected to reach USD 50 billion by 2025. The Indian medical device industry has a high import dependency, with imports accounting for around 80-85% of the total market share, as per a report by the Associated Chambers of Commerce and Industry of India. The medical device industry in India is estimated to employ around 8 million people, both directly and indirectly and is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The government has recently introduced the Medical Device Rules, 2017, to streamline the regulatory framework for medical devices. India has set ambitious targets to become a major exporter of Medical Devices and increase in-house manufacturing of Medical Devices to reduce imports. MDRTA is set to do its bit to contribute to this goal of the country.

What is MDRTA solving

Currently, India is importing up to 80% of its medical devices. With the targeted growth in the industry and following the ‘Make in India’ mantra, the nation aims to become an exporter of medical devices soon. To achieve this ambitious target, all the agencies are working at their best, including regulatory bodies like CDSCO, ICMR and State regulatory bodies etc. CDSCO is updating information at a high speed via notifications and updates around MDR, 2017. This is also bringing up new challenges of assimilating this huge amount of information. Manufacturers, innovators, importers, distributors, consultants and even regulatory officials are facing challenges in converting this huge amount of information into knowledge.

MDRTA is set to democratize this knowledge for everyone with the power of AI. MDRTA is your assistant for helping you with MDR-related consultations and support. It is bringing automation in communication and knowledge sharing, which is very important for scaling and achieving the targets which India has set up for itself.

Components of MDRTA

  • Device Classification: As per MDR 2017, all medical devices and in-vitro diagnostic devices are to be classified into four classes – Class A, Class B, Class C and Class D. This classification happens on the basis of the intended use of a device and the risk it poses to the patient during its operation. MDRTA understand the rules, parameters and conditioning mentioned in MDR, 2017 to classify any device, and it also keeps itself updated with the list of devices notified by CDSCO. By understanding the intended use of a device, it can tell under which class similar devices have been notified by CDSCO, and what is the rationale behind its being in a particular class as per MDR 2017.
  • MDR FAQs: MDR is a 200+ page rule set. It has eight schedules, and 12 chapters and it talks about 40+ different forms used for different purposes. It has exhaustive information about provisions related to manufacturing, importing, storing, distributing, licensing etc of Medical Devices. MDRTA provides all this detailed information in a conversational format to users. This AI-based engine can answer your queries around MDR.
  • Community: MDRTA offers a central, moderated and active discussion forum, where users can discuss their doubts and concerns related to their specific situation, and experts can answer those queries. It provides a healthy and formal platform to have meaningful discussions about the Medical Device Industry.
  • Resources: MDRTA has created a repository of important documents and resources for all. These resources are otherwise also available in the public domain, but not compiled and arranged in the way that MDRTA does. The resources repository remains updated with the most relevant and related documents for the Medical Device Industry.
  • Device Management: Users, consultants and other stakeholders can manage their devices’ documentation and other important information on the platform itself. MDRTA offers secure and private access to every unique user to manage their own activity privately on the platform.

How does it work?

Simply register/log in with your preferred social media account (google, facebook, apple etc) and start using MDRTA! You can keep on using selected features of MDRTA like “Community” and “Resources” etc for free for life. There are some paid features in the platform, for which you may need to pay as per your usage of the platform.