Title:Current Challenges and Issues in Indian Regulations of Medical Devices
Volume: 19
Issue: 5
Author(s): Rohit Bhatia, Shubham Singh, Ananya Parashar and Arti R. Thakkar*
Affiliation:
- Amity Institute of Pharmacy, Amity University Uttar Pradesh (AUUP), Sector 125, Noida 201303, Uttar Pradesh, India
Keywords:
Central drugs standard control organization (CDSCO), medical device regulation (MDR), issues, challenges, quality management system, materiovigilance.
Abstract: The study's objectives are to highlight the significance of medical devices, investigate the
prospective expansion of the Indian market, look at the legislative changes made possible by MDR
2020, and deal with the ongoing issues with cost, quality, and adverse responses. The research aims to
enhance the Indian medical devices sector by offering insightful observations and suggestions. This
study intends to highlight the significance of medical devices, assess the prospective growth of the Indian
industry, look at the regulatory changes brought about by MDR 2020, and address the ongoing
issues with cost, quality, and adverse responses. The goal of the research is to help the Indian medical
devices business grow by offering helpful insights and practical suggestions. The improvement of
people's well-being and health depends heavily on medical technologies. The usage of medical devices
is expected to rise as technology develops and illnesses spread. The Indian medical device industry
is expected to grow to a market value of USD 50 billion by 2025, placing it fourth in Asia. The "Atma
Nibbar Bharat" strategy, which emphasizes independence, is anticipated to support the expansion of
India's medical device industry. Before the passage of the Medications and Cosmetics Act of 1940,
there were no explicit regulations controlling medical devices, which resulted in their designation as
medications. The Medical Device Regulation (MDR) was initially announced in 2017, nevertheless,
and went into effect in January 2018. The Indian medical device sector was greatly impacted by the
change of this guideline paper into MDR 2020. For testing and altering equipment that comes within
the new criteria, the amended legislation offers a wider range of options. Despite these positive adjustments,
problems still exist. Significant drawbacks include unregulated pricing, difficulties with
quality control, and negative responses to medical equipment. This essay covers these topics in extensive
detail and includes pertinent advice. It is stated which department is in control of handling these
issues. To successfully address these issues, thorough examples, case studies, and solutions are given.
In conclusion, this abstract emphasizes the significance of medical devices, the market's potential for
growth in India, MDR 2020's legislative adjustments, as well as the ongoing difficulties related to
cost, quality, and bad responses. The essay seeks to solve these problems by providing insightful analysis
and suggestions.
