Securing the CDSCO license for gynaecological medical devices is mandatory to launch your devices in the Indian medical device market. This requirement is in place to protect the public health and maintain the standard of the Indian healthcare system. To manufacture...
Operation theatre medical devices have a crucial role in facilitating surgeries and ensuring positive patient outcome. In addition to specialized equipment, basic general operation theatre medical devices, such as surgical table, have equally important roles....
India has a rapidly growing domestic medical device manufacturing industry. However, India still heavily relies on medical device imports to fulfil the requirements of the healthcare system. To import medical devices into India, importers have to mandatorily obtain a...
When manufacturing medical devices, safety, regulatory compliance, performance, and resilience are the major factors to focus on. Furthermore, while choosing medical device manufacturing materials, biocompatibility, durability, and regulatory compliance are some of...
Planning to market your medical device in the US? Then, you will have to secure the US FDA 510(k) approval. For which you will require proper documentation and have to select the appropriate predicate device. You will need the predicate device to prove substantial...