IMDR Licence to Manufacture for Sale or for Distri...

IMDR Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device License No. MFG/MD/2025/000180 Medical devices are categorized by risk level, with Class A representing the lowest-risk category. These non-invasive or minimally invasive devices - such as thermometers, tongue depressors, and non-sterile bandages - typically only require self-declaration of conformity in most regulatory systems. Class B devices present slightly higher but still moderate risks, including minimally invasive products like hypodermic needles, suction cannulas, and surgical gloves. The fundamental distinction between these classes lies in their risk profile and corresponding regulatory pathway - while Class A devices benefit from streamlined approval, Class B devices warrant greater scrutiny to ensure patient safety while remaining relatively accessible compared to higher-risk categories