Background: A medical device is any tool, implant, or IVD that is intended to manage, ameliorate, avert, or identify a human disease. Simple thermometers, bandages, implants, and so on are examples. A medical device’s primary intended use is not accomplished chemically on or within the skin, nor does it require metabolization to accomplish that primary intended use. Medical devices are classified differently by different regulatory bodies. The FDA divides medical devices into three categories, whereas India and Europe divide them into four categories based on risk. Each regulated country has its own set of medical device regulations and guidelines. Purpose: The medical device sector is expected to showcase a remarkable journey of growth by 2029, achieving a 718.92-billion-dollar market with a CAGR of 5.5% over the expansion period of 2022–2029, making it the fastest-growing global market. The earlier medical device has simple inspection and testing but Post Covid19 due to an increase in imports, takeover from foreign manufacturers, and fostering innovation medical devices took off, becoming ever more sophisticated and widely available therefore the need for manufacturing and product standards was recognized, the new regulation was framed and regulatory specialists were recruited. Thereby led to the emergence of a whole new regulatory system and a post-marketing surveillance strategy. Methods: The analysis of current market size, share, and trends on medical devices for USA, Europe, and India was performed and current regulatory standards were observed which are continuously becoming stringent for all the countries with the advancement of technology. Conclusions: The Medical devices sector is the leading growing market. With the advancement in the medical device sector such as cybersecurity, digitalization, data privacy, and innovation, new entrants and new manufacturers the doors for entrepreneurship will open thus, it becomes highly important and necessary to introduce comprehensive regulatory guidelines for safety, effectiveness and customer protection, and satisfaction. The regulated medical devices sector will reach new heights with stringent vigilance and transparency benefitting society.
Almir, B., Halida, A., & Gurbeta, P., (2021)., Artificial Intelligence in Medical Devices: Past, Present, and Future.Psychiatria Danubina 33(3), 336- 341.https://doi.org/10.5005/sar-1-1-2-101.
Austin, N. (2019). Grand View Research: U.S. Medical Device Manufacturers Market Size, Share & Trends Analysis Report By Type And Segment Forecasts. Retrieved October 4, 2022, from https://www.grandviewresearch.com/industry-analysis/us-medical-device-manufacturers-market/methodology.
BioSpectrumindia Looking at reasons for the high growth of the medical devices industry (2020). Retrieved October 4, 2022, from https://www.biospectrumindia.com/views/59/17367/looking-at-reasons-for-high-growth-of-medical-devices-industry.html.
Colhn, N. (2022), Market Data Forecast: Europe Medical Devices Market Research Report – Segmented By Type, End-user, and Country – Industry Analysis on Size, Share, Trends, COVID-19 Impact & Growth Forecast. Retrieved Oct. 4, 2022, from https://www.marketdataforecast.com/market-reports/europe-medical-devices-market.
Cybersecurity, USFDA (2022), Retrieved from https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity.
Daigle, B., & Torsekar, M., (2019). The EU Medical Device Regulation and the U.S. Medical Device Industry.Journal of International Commerce and Economics. 1-22 ,Retrieved from https://www.usitc.gov/publications/332/journals/eu_medical_device_regulation_us_medical_device_industry.pdf.
Data from the Ministry of Commerce, compiled by the Association of Indian Manufacturers of Medical Devices, Import of medical devices up by a record, biospectrumindia. (2019) Retrieved from https://www.biospectrumindia.com/reports-white-papers/59/14035/import-of-medical-devices-up-by-record-24.html.
Draft National Medical Device Policy, Association of Indian Medical Device Industry. (2017). Retrieved from https://aimedindia.com/comments-activities/details?k=national-medical-device-policy2017-1436977100.
Henry, K. (2022, June 20). Fortune Business Insights: Medical Device Market Size, Share & Covid Impact Analysis By Type, End-user and Regional Forecast. Retrieved October 4, 2022, fromhttps://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085.
Manu, A., Manas, M., (2021). A review of medical device regulations in India, comparison with European Union and way-ahead. National Library of Medicine 13(1), 3–11, Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8815674/.
Markan, S., Nath, R., & Sharma, J. (2020). Indian Medical Device Sector -Blue Print & Regulatory Policy Roadmap. International Journal of Drug Regulatory Affairs, 8(2), 25-35. https://doi.org/10.22270/ijdra.v8i2.392.
Sahadeva, A. (2022, June 21). Global Legal Insights: Pricing & Reimbursement Laws and Regulations EurAsian Matters. Retrieved October 4, 2022, fromhttps://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/india.
Sethi, R., Rohin, S., & Popli, H., (2017). Medical Devices Regulation in the United States of America, European Union and India: A Comparative Study. Pharm Regul Aff. 6(1), 179-183 https://doi.org/10.4172/2167-7689.1000179.
Shah, R., Anuja, K., & Goyal, K. (2008). Current Status of the Regulation for Medical Devices. Indian Journal of Pharmaceutical Science, 70(6), 695-700. https://doi.org/10.4103/0250-474X.49085.
The European Parliament and of the Council, Official Journal of the European Union (2017). Retrieved from https://eur-lex.europa.eu/legal-content /EN/TXT/?uri=CELEX%3A32017R0745.
Thomas, L. (2022, May 31) News-Medical.Net: The Importance of Regulating Medical Devices, Retrieved October 4, 2022, from https://www.news-medical.net/health/The-Importance-of-Regulating-Medical-Devices.aspx.
Venugopal, N., Senthil M., & Gowthamarajan, K., (2020). Advancements in Regulatory Framework For Medical Device Regulations In India. International Journal of Pharmaceutical Research. 1(1), 745-755. Retrieved from https://www.researchgate.net/publication/343738548_Advancements_in_Regulatory_Framework_For_Medical_Device_Regulations_In_India
| Periodicity | Biannually |
| Issue-1 | May |
| Issue-2 | November |
| ISSN Print | 2321-2217 |
| ISSN Online | 2321-2225 |
| RNI No. | CHAENG/2013/50088 |
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