Medical Device Regulations and Standards

Healthcare, Medical Devices Design and Development, Regulations, Standards, Calibrations, and Testing

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India is one of the top 20 global devices market and it is the fourth largest market in Asia. In spite of that, innovations of small and medium scale Medical Device Industries in India are not reaching the needy patients.

  • The lack of comprehensive resource and expertise on the stringent regulations and standards requirements are seen as the reasons for the inability of the Indian Medical Device Industries to compete in the global market.

  • These regulations are constantly being changed from time to time and also vary from country to country.

  • Recently, the Medical Device Rules has also been introduced to improve the quality of products and promote exports.

  • Therefore, there is a requirement for a dedicated centre of excellence for Medical Device Regulations and Standards to serve Indian stakeholders to accelerate their innovation and enhance their ability to compete with international players.

Medical Device Regulations and Standards

S. Ramakrishnan

Principal Investigator



Aim: Establishment of a Centre of Excellence for Medical Device Regulation and Standards at IIT Madras

Functions: Research, generate expertise and help stakeholders to implement global regulations and standards

Key Objectives:

  • Facilitate Indian industry to accelerate medical device design and development through comprehensive knowledge on local and global regulations and standards,
  • Help manufacturers to understand the regulations, standards and quality system requirements,
  • Facilitate regulatory authorities in making informed decision on public health policies related to medical device safety, approvals and monitoring,
  • Provide researchers country-specific data and essential training for design, development, verification and validation of medical devices,
  • Generate high quality human resource in the areas of medical device design, development, manufacturing, regulatory and hospital auditing, and
  • Participate in open innovation under global harmonization efforts

Expected deliverables of the research

  • Established strategic partnerships with all healthcare stake-holders in India and abroad, particularly in SMEs, government regulatory authorities, international standard organizations and leading international universities
  • Established country specific normative database of Medical Images and Signals, to assist industries in design and validation and to facilitate policy makers to address public health issues
  • Demonstrated ability to participate in standards development
  • Demonstrated continuous professional development opportunities for quality system health audit experts
  • Generation of monographs, publications and resources of standards, regulations and multi-media materials for on-demand multi-modal higher learning materials
  • Evolution of independent competent nodal national system for comprehensive regulatory and standard services to medical device industry and practitioners

Current status


International Collaborations

  • Germany:

    • Department of Psychiatry, Psychotherapy and Psychosomatics: RWTH Aachen

    • PLRI institute for Medical Informatics: Technische Universität Braunschweig

  • Australia:

    • Melbourne School of Engineering: University of Melbourne

    • Department of Electrical and Biomedical Engineering: RMIT University

  • USA:

    • School of Biomedical Engineering, Science and Health Systems: Drexel University

    • Department of Neurosurgery: Linda Loma State University

Societal impact

The activities of the center will have many potential impacts on the healthcare aspects of the society. A few very visible impacts would be: Society will be assured of affordable pervasive healthcare that is regulated, legal and ethical.

  • The regulatory activities of the center would result in enhanced quality of life in elderly through use of reliable and standard self-monitoring devices and wearables.
  • Society would be benefit by enhancing their knowledge in wellness pointers which would be shared by the center through various means.
  • The regulated technology would fill in the gap between rural-urban divide, and in addition to enhancing the quality of diagnosis through calibrated devices.

Sustenance statement