CDSCO drug labeling requirements in India are governed by the Drugs & Cosmetics Act. These labelling requirements ensure that healthcare providers and patients can use medicines correctly and safely. Moreover, they also help prevent misuse of controlled...
Planning to start a disposable medical devices manufacturing business in India? Well, you have landed in the right place. This blog has got you covered from potential for the business to CDSCO license required. Potential for starting a disposable medical devices...
In India, the regulatory framework for investigational new drug (IND) is governed by the CDSCO under the DCGI. INDs are regulated by the New Drugs and Clinical Trials Rules, 2019 (with amendments in 2026). It ensures that investigational drugs undergo rigorous safety,...
Legacy IVD devices are IVDs legally CE-marked under the old EU In Vitro Diagnostic Directive (IVDD). They were CE marked before the EU In Vitro Diagnostic Regulation (IVDR) took effect. They are allowed to remain in the market during a defined transition period if...
Surgical bandages are low-risk non-invasive medical devices that do not directly sustain or support life. Additionally, their potential harm to patients is minimal. They are primarily used for external wound protection and healing. Hence, they are placed under limited...