India is aiming to locally manufacture and assemble medical devices. Various components and parts have to be imported to manufacture life-saving medical devices. However, while importing medical device components and essential parts, medical device manufacturers are...
Witnessing unprecedented growth, India aims to become a global medical device manufacturing powerhouse. India’s medical device industry is focusing on transforming from an import dependant sector to a self-reliant manufacturing hub. The goal of India’s medtech...
In this blog, we have provided an overview of what is medical device equivalence. Additionally, we have discussed the criteria and requirements that have to be fulfilled. Moreover, we have highlighted the common challenges encountered while trying to prove...
Medical devices form the backbone of the healthcare sector. The diagnosis and prognosis of a disease or a medical condition depends on the effectiveness of the medical device. Hence, medical device entrepreneurs are constantly trying to tap into the potential of the...
Medical device industry is highly regulated. Various documents are required to demonstrate regulatory compliance. Standard operating procedures (SOPs) are one such essential document required for medical device approval and market launch. SOPs outline the framework...