What is ...?

Medical Device Reporting (MDR) is a post-market surveillance tools that the Food and Drug Adminis

The complex registration process of medical devices in Japan makes the market one of challenging

The Medical Device Single Audit Program (MDSAP) allows conducting a single Regulatory audit of a

Post Market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR) compose critical

Medical Device Licence (MDL) and Medical Device Establishment Licence (MDEL) are the licenses iss

The Notified Devices are the list of devices regulated under Medical Devices Rules (MDR), 2017 by

Summary of Safety and Clinical Performance (SSCP) is a new Regulatory requirement applicable for

In January 2016, India’s Central Drugs Standard Control Organisation (CDSCO) introduced S