Previously in India, intimate lubricants were generally treated as cosmetic or personal care products rather than medical devices. However, CDSCO recognized that lubricants, when used for intimate or reproductive purposes, pose health risks. Therefore, they require...
We have prepared this detailed guide to help you start a blood collection tube manufacturing business in India. Our guide covers raw materials required and process of manufacturing blood collection tubes. Furthermore, we have detailed the regulatory guidelines for...
Implantable medical devices are surgically or medically introduced entirely or partially into the human body. They are intended to remain there after the procedure. These specialized devices serve critical medical purposes, such as supporting, replacing, or augmenting...
A thermometer provides a quick, non-invasive, and reliable way to measure body temperature, which is an indicator of health status. By detecting fever, hypothermia, or abnormal fluctuations, thermometers help clinicians and patients identify infections, monitor...
The 510(k) pathway is used for medical device approval in the US when the device has a predicate. A predicate device is an already cleared product with similar intended use and technological characteristics. Manufacturers must demonstrate substantial equivalence by...