Cleanrooms have a vital role in maintaining the controlled environments necessary for manufacturing sterile medical devices. They offer a sterile and specialised environment. Medical device manufacturers will have to establish effective clean rooms to maintain a...
Japan is a top global exporter of medical devices, especially in diagnostic and imaging equipment. Japan has a reputation for manufacturing high-quality and reliable products. India has a growing medical device market and increasing demand for advanced healthcare...
Planning to import medical devices from USA? With over 27 years of experience and more than 600 clients, we have extensive knowledge of the CDSCO regulations. We will leverage our expertise and industry knowledge to help you easily get the CDSCO MD 15 import license....
Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The US FDA 510(k) approval process authorizes the marketing of medical devices in the US. Timing, completion, and accuracy are of paramount...
Wearable defibrillators are non-invasive lifesaving medical devices. Hence, their manufacturing process is strictly regulated. In this blog, we have discussed the wearable defibrillator manufacturing process. Additionally, we have highlighted the regulations for...
Currently, India’s medical device market heavily relies on imports. UK is among the top countries from which India imports medical devices. The demand for UK-imported medical devices is strong and projected to grow. Furthermore, the India-UK Free Trade Agreement...