Central Drugs Standard Control Organization (CDSCO) regulates and monitors all medical devices in India. The CDSCO MD9 license permits the manufacture of class C and D medical devices in India. Class C and D medical devices are strictly regulated owing to their risk...
The CDSCO regulates the import of medical devices into India. Hence, you have to mandatorily secure the CDSCO MD15 import license to import your medical devices into India. It is the gateway for importing and selling imported medical devices in India. In this...
CDSCO notice, dated May 4, 2026, stated that long-pending applications on the SUGAM portal awaiting query response will be rejected. It directs all applicants to respond to regulatory queries within 30 days of issuance. The notice highlights that numerous applications...
Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for all medical devices in India. The CDSCO MD5 license grants the permission to manufacture class A and B medical devices in India. Class A and B medical devices are low to moderate risk...
Conducting clinical performance evaluation is critical to ensure the IVDs are accurate and reliable. Notably, IVD clinical performance evaluation is regulated in India. You have to mandatorily secure the MD 25 license to conduct clinical performance evaluation for new...