One world, one forum: Harmonizing the medical device regulatory framework

India is late when it comes to recognizing the versatility of medical devices and their intended use. Medical devices are an important part of healthcare, yet they are an extraordinarily heterogeneous class of products. Whether used externally or internally, on humans or animals, for diagnosis, treatment, prevention, mitigation, or conception of diseases or disorders, medical devices have become the face of the healthcare sector. The global medical devices market size was valued at 518. 46 billion in 2023 and is projected to grow from 542. 21 billion in 2024 to 886. 60 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 6. 3%. While the US, EU, and Japan lead the MedTech sector, India has historically focused on pharmaceuticals, leading to an 80% import dependency in its MedTech sector. Nevertheless, the introduction of the Indian Medical Devices Rules, 2017, marked a significant turning point, making India the 4 th largest Asian market, projected to reach 50 billion by 2030. However, regulatory harmonization remains a concerning challenge due to diverse frameworks, limited global participation, high compliance burdens, market access barriers, and insufficient international collaboration. The article aims to advocate for a unified global framework under the “One World, One Forum” concept, comparing the Indian medical devices regulation with global market leaders, including the US, the EU, and Japan. The study aims to examine the impact of regulatory frameworks through an extensive retrospective review of literature. The paper also aims to propose promising strategies to enhance exports, streamline approvals, and ensure equitable access to safe medical devices.