The German medical device regulatory landscape presents specific hurdles for manufacturers seeking to launch the European market. The Central Drug Standard Control Organization (CDSCO) of India, while focussed on domestic regulations, also plays a role in facilitating the international journey of In

Gaining entry into the Indian medical device market requires a comprehensive understanding of its stringent regulations. To ensure smooth licensing, manufacturers must meticulously conform with all applicable requirements. This entails conducting thorough risk assessments, obtaining necessary certif

Entering the Indian market for medical devices presents a unique opportunity for manufacturers. To successfully launch in this growing sector, it's crucial to navigate the regulatory framework set by the Central Drugs Standard Control Organization (CDSCO). The CDSCO registration process can seem int

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices in accordance with the Medical Device Rules 2017 India. For medical device registration India on the Sugam portal, one essential requirement is the submission of a Plant Master File (PMF). This document provi